Primary Outcomes

Description: Blood pressure group: 1) Essential arterial hypotension, 2) normotension and 3) Essential arterial hypertension. Comorbidities: As describe in the protocol, as a summary: 1) cardiovascular, 2) metabolic, 3) Endocrine, 4) psychiatric disorders: depression and panic disorder, 5) orthostatic intolerance: neurally mediated syncope, vasovagal syncope, inappropriate sinus tachycardia, Postural orthostatic syndrome, carotid sinus hypersensitivity; 6) others: chronic fatigue syndrome, fibromyalgia, arthritis, autoimmune diseases, pulmonary thromboembolism, OSA (obstructive sleep apnea), Alzheimer disease, Parkinson disease, others dementias, epilepsia, nephropathies, and others. Cardiovascular mortality Total mortality

Measure: Relationship between Blood pressure group and comorbidities

Time: A 7-year prospective study

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Description: Adaptability group: Hyper adaptable, normal adaptability, hypo adaptable. Comorbidities: As describe in the protocol, as a summary: 1) cardiovascular, 2) metabolic, 3) Endocrine, 4) psychiatric disorders: depression and panic disorder, 5) orthostatic intolerance: neurally mediated syncope, vasovagal syncope, inappropriate sinus tachycardia, Postural orthostatic syndrome, carotid sinus hypersensitivity; 6) others: chronic fatigue syndrome, fibromyalgia, arthritis, autoimmune diseases, pulmonary thromboembolism, OSA (obstructive sleep apnea), Alzheimer disease, Parkinson disease, others dementias, epilepsia, nephropathies, and others. Cardiovascular mortality Total mortality

Measure: Relationship between adaptability group and comorbidities

Time: A 7-year prospective study

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Description: Blood pressure group: 1) Essential arterial hypotension, 2) normotension and 3) Essential arterial hypertension. Adaptability group: Hyper adaptable, normal adaptability, hypo adaptable. Comorbidities: As describe in the protocol, as a summary: 1) cardiovascular, 2) metabolic, 3) Endocrine, 4) psychiatric disorders: depression and panic disorder, 5) orthostatic intolerance: neurally mediated syncope, vasovagal syncope, inappropriate sinus tachycardia, Postural orthostatic syndrome, carotid sinus hypersensitivity; 6) others: chronic fatigue syndrome, fibromyalgia, arthritis, autoimmune diseases, pulmonary thromboembolism, OSA (obstructive sleep apnea), Alzheimer disease, Parkinson disease, others dementias, epilepsia, nephropathies, and others. Cardiovascular mortality Total mortality

Measure: Relationship between blood pressure group, adaptability group and comorbidities

Time: A 7-year prospective study

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Secondary Outcomes

Description: Blood pressure group: 1) Essential arterial hypotension, 2) normotension and 3) Essential arterial hypertension. Habits: smoke and drink Anthropometric variables: Body mass index, waist, hip Metabolic variables: Fasting glucose, 2 hs postprandial plasma glucose, insulin plasma levels, homoeostasis model assessment (HOMA), total cholesterol, LDL, HDL, triglycerides. Endocrine variables: plasma cortisol, free cortisol in 24 hs. urine, epinephrine, norepinephrine, metanephrines, vanilmandelic acid, ACTH, aldosterone, renin, thyrotropine, free thyroxine, triiodothyronine, testosterone Electrocardiogram: HR; PR interval, QRS complex, cQT interval Holter variables: HR, standard deviation of NN intervals (SDNN) and sympathovagal balance, at day, night and 24 hs. ABPM: Systolic, diastolic, and heart rate, at day, night and 24 hs., BP matinal surge.

Measure: Relationship between blood pressure group, habits and anthropometric, metabolic, endocrine, Electrocardiogram, Holter, ambulatory blood pressure monitoring (ABPM)

Time: A 7-year prospective study

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Description: Blood pressure group: 1) Essential arterial hypotension, 2) normotension and 3) Essential arterial hypertension. Adaptability group: Hyper adaptable, normal adaptability, hypo adaptable. Habits: smoke and drink Anthropometric variables: Body mass index, waist, hip Metabolic variables: Fasting glucose, 2 hs postprandial plasma glucose, insulin plasma levels, HOMA, total cholesterol, LDL, HDL, triglycerides. Endocrine variables: plasma cortisol, free cortisol in 24 hs. urine, epinephrine, norepinephrine, metanephrines, vanilmandelic acid, ACTH, aldosterone, renin, thyrotropine, free thyroxine, triiodothyronine, testosterone Electrocardiogram: PR interval, QRS complex, Heart rate, cQT interval Holter variables: HR, SDNN and sympathovagal balance, at day, night and 24 hs. ABPM: Systolic, diastolic, and heart rate, at day, night and 24 hs., BP matinal surge.

Measure: Relationship between blood pressure group, adaptability group, habits anthropometric, metabolic, endocrine, electrocardiographic, Holter, ambulatory arterial blood pressure monitoring.

Time: A 7-year prospective study

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Description: Blood pressure group: 1) Essential arterial hypotension, 2) normotension and 3) Essential arterial hypertension. Adaptability group: 1) Hyper adaptable, 2) normal adaptability and 3) hypo adaptable. Habits: smoke and drink, exercise Anthropometric variables: Body mass index, waist, hip Metabolic and other variables: Fasting glucose, 2 hs postprandial plasma glucose, insulin plasma levels, HOMA, total cholesterol, LDL, HDL, triglycerides; thyrotropine, Holter variables: HR, standard deviation of NN intervals (SDNN) and sympathovagal balance, at day, night and 24 hs. ABPM: Systolic, diastolic, and heart rate, at day, night and 24 hs., BP matinal surge.

Measure: For metabolic disorders what it matters the most: the anthropometric variables vs blood pressure group vs adaptability group

Time: A 7-year prospective study

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Description: Adaptability group: Hyper adaptable, normal adaptability, hypo adaptable. Habits: smoke and drink Anthropometric variables: Body mass index, waist, hip Metabolic variables: Fasting glucose, 2 hs postprandial plasma glucose, insulin plasma levels, HOMA, total cholesterol, LDL, HDL, triglycerides. Endocrine variables: plasma cortisol, free cortisol in 24 hs. urine, epinephrine, norepinephrine, metanephrines, vanilmandelic acid, ACTH, aldosterone, renin, thyrotropine, free thyroxine, triiodothyronine, testosterone Electrocardiogram: PR interval, QRS complex, Heart rate, cQT interval Holter variables: HR, SDNN and sympathovagal balance, at day, night and 24 hs. ABPM: Systolic, diastolic, and heart rate, at day, night and 24 hs., BP matinal surge.

Measure: Relationship between adaptability group, habits and anthropometric, metabolic, endocrine, Electrocardiogram, Holter, ambulatory blood pressure monitoring (ABPM)

Time: A 7-year prospective study

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Other Outcomes

Description: Clinical syncope characteristics (age of first syncope, number of syncope episodes, trauma, duration, clinical score, convulse, sphincter relaxation, etc.) Syncope cause Blood pressure group Adaptability group Prognosis

Measure: Syncope Registry

Time: Up 100 weeks

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Description: TTT protocol: describe the protocol, the time at positive response, nitroglycerine use, autonomic and hemodynamic variables. TTT outcome for syncope: positive or negative TTT other outcomes: 1) Chronotropic incompetence, 2) arterial orthostatic hypotension, 3) carotid hypersensitivity, 4) POTS, 5) IST The relationship between TTT results and Clinical score for syncope in regard to: syncope behaviour and other orthostatic intolerance entities, symptoms and comorbidities. The relationship between neurally mediated syncope response at the TTT and comorbidities.

Measure: Tilt table testing (TTT) registry

Time: Up to 100 weeks

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Description: EPS variables: AH, AV, CL, sino atrial conduction time (SACT), sinus node recovery time (SNRT), corrected sinus node recovery time (CSNRT), response to Isoproterenol, intrinsic heart rate Diagnosis: control, sick sinus syndrome, IST, chronotropic incompetence at the TTT HR at the ECG HR at the Holter monitoring HR at the TTT HRV at the Holter monitoring Syncope, cardiac or neurally mediated HR at the physical treadmill test Relationship with the blood pressure group Relationship with the adaptability group

Measure: Sinus node function at the electrophysiological study (EPS)

Time: Up to 100 weeks

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Description: Define how the blood pressure group and/or the adaptability group may add to the already known and include in this registry, in the diagnosis of cardiovascular complications as coronary artery disease, cerebrovascular disease, peripheral artery disease, nephropathy.

Measure: Score for coronary artery disease

Time: Up to 200 weeks

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Description: Blood pressure group: 1) Essential arterial hypotension, 2) normotension and 3) Essential arterial hypertension. Adaptability group: Hyper adaptable, normal adaptability, hypo adaptable. Comorbidities: As describe in the protocol, as a summary: 1) cardiovascular, 2) metabolic, 3) Endocrine, 4) psychiatric disorders: depression and panic disorder, 5) orthostatic intolerance: neurally mediated syncope, vasovagal syncope, inappropriate sinus tachycardia, Postural orthostatic syndrome, carotid sinus hypersensitivity; 6) others: chronic fatigue syndrome, fibromyalgia, arthritis, autoimmune diseases, pulmonary thromboembolism, OSA (obstructive sleep apnea), Alzheimer disease, Parkinson disease, others dementias, epilepsia, nephropathies, COPD, and others. Mortality

Measure: Neurally Mediated Syncope: further of the transient lost of consciousness (TLC)

Time: A 7-year prospective study

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Description: Blood pressure group: 1) Essential arterial hypotension, 2) normotension and 3) Essential arterial hypertension. Adaptability group: Hyper adaptable, normal adaptability, hypo adaptable. Psychiatric variables: Big Five Questionary (BFQ) for personality. Modify of the Coping Scale (Scale of modified coping strategies) Zung questionary for depression and anxiety MINI in those patients with moderate or severe depression and/or anxiety at the Zung questionary

Measure: Psychobiotype: relationship between biological and psychological variables

Time: Up to 100 weeks

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Description: High sodium intake in the diet is recognized as a risk factor for hypertension development. Essential hypotension population is advised to increase the sodium (at least 10 grams a day) and water intake (at least 2 liters a day), or as much as possible, several have taken Fludrocortisone (is not a exclusion criteria). Normal blood pressure population are advised to have a normal or low sodium intake. Physical exercise is recommended in both groups. This registry is a good opportunity to test how important sodium diet is to induce hypertension, or if by the contrary adaptability could prevail over high sodium intake in this registry. Blood pressure groups: essential hypotension and normotension and those with new essential hypertension. Adaptability groups. The results will be adjusted for age, gender and BMI.

Measure: The role of high sodium intake in the development of essential hypertension. Comparison between essential hypotension (high sodium intake) vs normotension population (normal or low sodium intake) in the follow-up.

Time: 4 years

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Description: Consistent bradycardia in the ECG at the office and normal HR in the holter monitoring or the contrary. There are patients with complaints that may be attributed to bradycardia, low blood pressure, hypothyroidism, or other entities. Some patients very often have bradycardia in the ECG taken in the office and normal HR in the 24 Holter monitoring, the opposite is also possible. Patients with bradycardia (without medication or physiological condition as exersice affecting heart rate) in at least 2 ECG (less 60 bpm) and at least 2 Holter monitoring will be analyzed, Other variables to consider are: Age, gender, blood pressure group, adaptability group, maximum HR in the treadmill test, white coat or masked hypertension, Tilt-Table-test result or syncope cause, Electrophysiological study if available. The acknowledge of this phenomenon could have clinical implications in the diagnosis of sick sinus syndrome and physiopathological ones.

Measure: White coat effect in the heart rate or masked bradycardia.

Time: 1 year

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Description: Bradycardia is the classical presentation form for sinus node dysfunction, mainly when associated with symptoms. Chronotropic incompetence is also a manifestation. Absence of medications with effects on the heart rate (HR) must be ruled out. Variables HR at the ECG, Holter monitoring, stress text, and at the physical examination previous to pacemaker implantation, Electrophysiological study (EPS): Basic cycle length, Sino-atrial conduction time, Sinus node recovery time, Corrected sinus node recovery time, Intrinsic HR when available 3. Pacemaker variables: HR at day and night or rest time Percentage of stimulation in A and V chambers 4. Syncope: Clinical characteriscs and clinical score Tilt table test results Trans Thoracic Echocardiogram in rest and or stress text Hypothesis: patients with ANSD will start to decrease the percentage atrial stimulation.

Measure: Reversible Bradycardia Mimicking Sinus Node Dysfunction as a Manifestation of Subacute Autonomic Nervous System Dysfunction (ANSD).

Time: 2 years

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Description: A non invasive, beat to beat BP monitoring, with the ability to measure BP, HR, Cardiac Output and Systemic Vascular Resistance (SVR) was started to use in the EHAR registry since May 2017. A description of this variables in the three BP groups will be collected in the data base (DB). This will allow to characterize whether SVR and/or CO maintain BP. Until now BP levels are related with prognosis. In the prognosis model SVR and CO will be add them to know what matter the most: BP levels, SVR and/or CO? In the EHAR registry a collection of the variables recognized as a risk factor for several comorbidities are available to adjust in multivariable analysis.

Measure: Description of the blood pressure hemodynamic profile at a medical office and their prognostic implications.

Time: Three years

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Primary Outcomes

Description: Modified Bruce Protocol with exercise duration limited by angina or angina equivalent

Measure: Change in Exercise Tolerance Test (ETT) duration

Time: Baseline and Month 6

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Secondary Outcomes

Description: Canadian Cardiovascular Society (CCS) angina classification

Measure: Change in patient functional status (CCS class)

Time: Baseline and Month 6

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Description: Average weekly angina episodes

Measure: Change in weekly angina frequency

Time: Baseline and Month 6

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Description: Average weekly nitroglycerin usage

Measure: Change in weekly nitroglycerin usage

Time: Baseline and Month 6

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Description: Seattle Angina Questionnaire

Measure: Change in quality of life

Time: Baseline and Month 6

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Description: Adverse events and clinical laboratory testing

Measure: Safety of Ad5FGF-4

Time: Through Month 6

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Description: Occurrence of clinically significant events

Measure: Long-term safety of Ad5FGF-4

Time: Through Month 60

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Primary Outcomes

Description: MI will be defined using the Third Universal Definition of Myocardial Infarction. Acute renal failure will be defined as Acute Kidney Injury stage III according to RIFLE criteria. Baseline creatinine will be considered the creatinine upon admission prior to the index operation. The above urine output criteria will be only used for patients who are in the ICU and have precise monitoring of their urinary output. For patients on the surgical floor only serum creatinine changes will be used for assessment of this endpoint. Coronary revascularization will be defined as a coronary artery bypass graft, or percutaneous coronary intervention (either angioplasty or stenting). Stroke will be defined as new unilateral neurological deficit that lasts for more than 24 hours, and is confirmed by a brain imaging modality (computed tomography or magnetic resonance imaging study) demonstrating new brain infarct.

Measure: A composite endpoint of all-cause post-randomization mortality, myocardial infarction (MI), coronary revascularization, acute renal failure, or post-randomization ischemic stroke up to 90 days after randomization.

Time: 90 days after randomization

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Secondary Outcomes

Description: Wound infection will be defined according to the Centers for Disease Control and Prevention (CDC) guidelines as a) positive wound culture, or b) drainage of pus from a wound, or c) suspicion of wound infection that was drained operatively. Pneumonia will be defined according to the CDC definition as chest radiograph with new or progressive infiltrate, consolidation, cavitation, or pleural effusion and any of the following: new onset of purulent sputum or change in character of sputum, or organism isolated from blood culture, trans-tracheal aspirate, bronchial brushings, or biopsy. Sepsis will be defined as a combination of two of the following systemic inflammatory response syndrome (SIRS) criteria, plus suspected or present source of infection. SIRS criteria will include the following: temperature greater than 38C, heart rate greater than 90 beats/min, WBC > 12,000 or < 4,000, or > 10% bands.

Measure: A composite endpoint of postoperative infectious complications at 90 days post-randomization: Infectious complications will include wound infections, pneumonia, and sepsis.

Time: 90 days after randomization

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Description: The diagnosis of cardiac arrhythmias will be based on EKG findings. Only arrhythmias that result in initiation of new treatment regimen (to include medications, implantable devices, or surgical intervention) during hospitalization will be recorded. CHF will require at least one of the following symptoms or signs new or worsening: dyspnea at rest, orthopnea, or paroxysmal nocturnal dyspnea and radiological evidence of heart failure or worsening heart failure and increase/initiation of established treatment. Cardiac arrest will be defined as the cessation of cardiac pump function activity that results in loss of consciousness and absence of circulating blood flow as evidenced by absent carotid pulse. Only episodes of cardiac arrest that are reversed will be collected under this endpoint. If they are not reversed the event will be categorized as death.

Measure: A composite endpoint of cardiac complications (other than MI) at 90 days post-randomization: Cardiac complications will include new cardiac arrhythmias that necessitate new treatment, new or worsening congestive heart failure (CHF), and cardiac arrest no

Time: 90 days after randomization

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Description: The investigators will determine vital status by telephoning participants after hospital discharge, by searching the electronic medical record and the National Death Index.

Measure: All-cause mortality at 1 year after randomization.

Time: 12 months after randomization

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Description: MI, coronary revascularization, acute renal failure, or postoperative ischemic stroke.

Measure: A composite endpoint of all-cause mortality,

Time: 30 days after randomization

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Description: Length of hospital stay

Measure: Length of hospital stay.

Time: At hospital discharge, up to 1 year

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Other Outcomes

Description: All cause postoperative mortality, Postoperative MI, Postoperative coronary revascularization, Postoperative stroke,Postoperative acute renal failure

Measure: The investigators will examine individual rates of the outcomes that consist of individual components of the primary endpoint.

Time: 90 days after randomization

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Primary Outcomes

Description: A composite of all-cause mortality, any myocardial infarction and any ischemia-driven revascularization

Measure: MACE

Time: 1 year

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Secondary Outcomes

Description: all-cause mortality, any spontaneous myocardial infarction and any ischemia-driven revascularization

Measure: MACE excluding peri-procedural MI (Major secondary endpoint)

Time: 1 year

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Description: Cardiovascular, non-cardiovascular and undetermined death

Measure: Death

Time: 1 month, 6 months, 1 year, 2 years and 3 years

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Description: Target vessel related and non-target vessel related MI

Measure: MI

Time: 1 month, 6 months, 1 year, 2 years and 3 years

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Description: The ischemia driven and non-ischemia driven TVR

Measure: Target vessel revascularization (TVR)

Time: 1 month, 6 months, 1 year, 2 years and 3 years

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Description: The The ischemia driven and non-ischemia driven Revascularization

Measure: Any coronary artery revascularization

Time: 1 month, 6 months, 1 year, 2 years and 3 years

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Description: Definite and probable stent thrombosis during acute, sub-acute, late, and very late phase according to the Academic Research Consortium (ARC)-2

Measure: Definite or probable stent thrombosis

Time: 1 month, 6 months, 1 year, 2 years and 3 years

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Description: PCI strategy changes following QFR and three-dimension quantitative coronary angiography (3D-QCA)

Measure: The PCI strategy changes based on the QFR and 3D-QCA

Time: During the procedure

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Description: Costs include direct clinical costs during the initial hospitalization and other resources used, main cardiovascular medication expenses, and outpatient and/or hospitalization expenses associated with MACE.

Measure: Cost during 1-year follow-up

Time: 1 month, 6 months, 1 year

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Description: QALYs determined using EuroQol five dimensions questionnaire (EQ-5D) in official Chinese version, to assess the quality of life.

Measure: Quality-adjusted-life-years (QALYs) index

Time: 1 month, 6 months, 1 year

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Primary Outcomes

Description: Mean minutes/day moderate to vigorous physical activity

Measure: ActiGraph GT9X Link Accelerometer

Time: Month 12

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Description: Participant's report of current level of state hopelessness. Total score range= 1 (better) to 4 (worse).

Measure: State-Trait Hopelessness Scale

Time: Month 12

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Secondary Outcomes

Description: Participant's report of exercise self-regulation level. Total score range= 1 (worse) to 7 (better).

Measure: Exercise Self-Regulation Questionnaire

Time: Month 12

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Description: Participant's report of perceived social support level. Total score range= 1 (worse) to 30 (better).

Measure: ENRICHD Social Support Inventory

Time: Month 12

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Other Outcomes

Description: Comorbidity score based on medical record abstraction. Total score range= 0 (better) to 100 (worse).

Measure: Charlson Comorbidity Index

Time: Week 1

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Description: Participant's report of participation level with exercise in home, community or cardiac rehabilitation program

Measure: Cardiac Rehabilitation Exercise Participation Tool

Time: Month 12

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Description: Participant's report of mean level of depressive symptoms. Total score range= 0 (better) to 27 (worse).

Measure: Patient Health Questionnaire-9

Time: Month 12

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Description: Participant's report of mean level of well-being. Total score range= 4 (better) to 20 (worse).

Measure: PROMIS-29

Time: Month 12

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Description: Participant's report of mean level state and trait hope. Total score range= 8 (worse) to 64 (better).

Measure: Snyder State Trait Scales

Time: Month 12

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Description: Participant's report of mean level of quality of life. Total score range= 1 (better) to 5 (worse).

Measure: EuroQol (EQ-5d-5L)

Time: Month 12

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Description: Participant's report of COVID-19 symptoms, diagnosis, testing, and social distancing. No score range (14 items).

Measure: Multi-Ethnic Study of Atherosclerosis (MESA) COVID-19 Questionnaire

Time: Month 12

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Description: Participant's report of impact on routine; income/ employment; access to food, medical and mental health care, extended family; and stress. No range (12 items)

Measure: Coronavirus Impact Scale

Time: Month 12

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Primary Outcomes

Description: Expression of the glycoprotein IIb/IIIa receptor (assessed by SUV) within thrombus in the arterial and venous circulation.

Measure: Ratio of 18F-GP1 standardised uptake values (SUV's) in thrombus compared with the SUVs recorded in the blood pool.

Time: 6 months from end of recruitment

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Secondary Outcomes

Description: Expression of the glycoprotein IIb/IIIa receptor (assessed by SUV) within thrombus in the arterial and venous circulation in all 5 disease states

Measure: Ratio of 18F-GP1 standardised uptake values (SUV's) in thrombus formed in each of the 5 disease states.

Time: 6 months from end of recruitment

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Primary Outcomes

Description: Inhibition of Platelet Aggregation

Measure: Platelet Inhibition

Time: Baseline

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Description: Inhibition of Platelet aggregation

Measure: Platelet Inhibition

Time: 15 minutes

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Description: Inhibition of Platelet aggregation

Measure: Platelet inhibition

Time: 45 minutes

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Description: Inhibition of Platelet aggregation

Measure: Platelet inhibition

Time: 60 minutes

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Description: Inhibition of Platelet aggregation

Measure: Platelet inhibition

Time: 90 minutes

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Description: Inhibition of Platelet aggregation

Measure: Platelet inhibition

Time: 120 minutes

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Description: Inhibition of Platelet aggregation

Measure: Platelet inhibition

Time: 180 minutes

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Description: concentration in blood (ng/mL)

Measure: RUC-4 Concentration

Time: Baseline

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Description: concentration in blood (ng/mL)

Measure: RUC-4 Concentration

Time: 15 minutes

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Description: concentration in blood (ng/mL)

Measure: RUC-4 Concentration

Time: 45 minutes

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Description: concentration in blood (ng/mL)

Measure: RUC-4 Concentration

Time: 90 minutes

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Description: concentration in blood (ng/mL)

Measure: RUC-4 Concentration

Time: 120 minutes

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Description: concentration in blood (ng/mL)

Measure: RUC-4 Concentration

Time: 180 minutes

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Description: Bleeding events, Injection site reactions,vital signs, ECG, laboratory results

Measure: Safety and Tolerability

Time: Baseline

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Description: Bleeding events, Injection site reactions,vital signs, ECG, laboratory results

Measure: Safety and Tolerability

Time: Hospital discharge

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Description: concentration in blood (ng/mL)

Measure: RUC-4 Concentration

Time: 240 minutes

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Description: Inhibition of platelet aggregation

Measure: Platelet aggregation

Time: 240 minutes

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Primary Outcomes

Description: Development of an electronic (e-HEALTH) framework structure for management of patients with known cardiovascular disease in COVID19 pandemic social context

Measure: Providing a special electronic platform (e-health) for remote managing cardiovascular outpatients

Time: 6 months

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Description: patients come into direct contact with the case coordinator, who provides ongoing assistance, including for connecting to devices that ensure real-time data transmission and directing to specialist teams that establish stage diagnosis and management / therapy behavior (including adjustment). doses, decisions to discontinue medication or to add medication);

Measure: Number of patients included in this platform

Time: 6 months

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Secondary Outcomes

Description: Will be the number of sessions per patient multiplied with the number of patients included

Measure: Number of consultations/sessions given

Time: 6 months

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Primary Outcomes

Description: Incidence of cardiomyopathies and/or venous thromboembolism at day 28

Measure: Determine the incidence of cardiomyopathies and venous thromboembolism

Time: 28 days

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Secondary Outcomes

Description: Incidence of mortality at day 28

Measure: Mortality

Time: 28 days

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Description: Number of day of using mechanical ventilation for each patients

Measure: Duration of mechanical ventilation

Time: hospitalisation duration

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Description: Incidence of shock during hospitalisation

Measure: Shock

Time: hospitalisation duration

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Description: Number of day at hospital

Measure: length of stay

Time: hospitalisation duration

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Description: Setting up or not of mechanical ventilation

Measure: Mechanical ventilation

Time: hospitalisation duration

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Description: Administration or not of renal replacement therapy

Measure: Renal replacement therapy

Time: hospitalisation duration

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Primary Outcomes

Description: Free wall rupture, acute ischemic mitral regurgitation, ventricular septal rupture

Measure: The primary endpoint is a composite of death from all causes and mechanical complications of acute myocardial infarction (MI)

Time: 3 months (between March 1 to May 31, 2019 and between March 1 to May 31, 2020 )

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Description: Compare the number of patients presenting to cardiology department with acute myocardial infarction in 2019 versus in 2020

Measure: Rates of patients presenting with acute myocardial infarction

Time: 3 months (between March 1 to May 31, 2019 and between March 1 to May 31, 2020 )

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Secondary Outcomes

Description: Correlation between clinical patient profile and the degree of affection of regions by COVID-19

Measure: Patient profile during admission for acute myocardial infarction

Time: 3 months (between March 1 to May 31

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Description: Correlation between the delay between onset of symptoms - first medical contact - coronary angiography room and the degree of affection of regions by COVID-19

Measure: Medical care times analysis

Time: 3 months (between March 1 to May 31)

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Description: Delay in minutes from symptom onset and STEMI (ST Segment Elevation Myocardial Infarction) diagnosis; and delay in minutes from onset of symptoms and primary PCI (percutaneous coronary intervention)

Measure: Medical care times analysis

Time: 3 months (between March 1 to May 31, 2019 and between March 1 to May 31, 2020 )

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Description: Correlation between the fate of patient and the degree of affection of regions by COVID-19: Number of days in cardiology department, Left Ventricular Ejection Fraction at discharge, presence of hemodynamic complications, presence of mechanical complications, transfer to intensive care unit, infection with COVID-19 during hospitalization, living status at discharge

Measure: Clinical evolution of patients

Time: 3 months (between March 1 to May 31)

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Description: Number of in hospital outcomes including orotracheal intubation, cardiogenic shock, arrhythmias (ventricular tachycardia of ventricular fibrillation) and in hospital cardiac arrest

Measure: Clinical evolution of patients

Time: 3 months (between March 1 to May 31, 2019 and between March 1 to May 31, 2020 )

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Description: Number of patient admitted in cardiology department with STEMI (ST Segment Elevation Myocardial Infarction)

Measure: STEMI (ST Segment Elevation Myocardial Infarction) admissions incidence rates

Time: 3 months (between March 1 to May 31, 2019 and between March 1 to May 31, 2020 )

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Description: Correlation between the number of patients who underwent systemic thrombolysis and the degree of affection of regions by COVID-19

Measure: Proportion of patients who underwent systemic thrombolysis

Time: 3 months (between March 1 to May 31)

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Description: Number of patient admitted in cardiology department for acute myocardial infarction infected with COVID-19

Measure: Proportion of patients infected with COVID-19

Time: 3 months (between March 1 to May 31)

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Primary Outcomes

Description: Acute myocardial infarction as diagnosed by ST segment elevation or depression or inverted T wave on 12-lead EKG and elevated levels of cardiac troponins above the 99% of the normal values. A. Acute MI (STEMI and NSTEMI). B. Aborted on non-aborted sudden cardiac death not attributed to a known etiology. C. Sustained or non-sustained ventricular tachy-arrhythmia not attributed to a known etiology. D. ICD shocks. 3. Absence of suspected or confirmed infection with the COVID19 virus. 4. Definite physical or psycho-social stressful trigger appearing in relation to the COVID-19 situation (lock down stress, financial stress, anger, depression, fear, sorrow, death of a significant person, eating binges, smoking binges, physical stress [carrying walking for shopping and carrying excess weights] ..etc) as judged by a unanimous agreement of three investigators in the steering committee.

Measure: Acute cardiovascular event triggered by COVID-19 stress

Time: 4 months

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Description: Typical ventricular tachycardia on 12-lead EKG or EKG monitor.

Measure: Ventricular tachycardia

Time: 4 months

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Description: acute neurological symptoms of hemiparesis or dysrthria due to brain ischemia proven by computerized tomography or magnatic resonance

Measure: acute stroke

Time: 4 months

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Description: Finding an episode of ventricular tachycardia on interrogation of ICD tracing

Measure: Implantable cardioverter defibrillator (ICD) shock

Time: 4 months

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Primary Outcomes

Description: (arterial dilation with residual lesion <50% at angiography and normal anterograde flow)

Measure: Successful cardiovascular intervention

Time: Until the end of the procedure

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Measure: Performed with the professional team positioned at> 2 meters from the patient for at least 50% of the duration of the intervention

Time: Until the end of the procedure

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Measure: absence of fatal complications caused by the procedure or acute non-fatal vessel occlusion during index admission

Time: Until the end of the procedure

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Primary Outcomes

Description: Number of patients undergoing primary angioplasty

Measure: Number of patients undergoing primary angioplasty

Time: March April 2019 and 2020

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Description: Number of patients undergoing primary angioplasty later 12 hours from symptoms onset;

Measure: Number of patients undergoing primary angioplasty later than 12 hours from symptoms onset;

Time: March April 2019 and 2020

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Description: Number of patients undergoing primary angioplasty later than 30 minutes from PCI hospital admission

Measure: Number of patients undergoing primary angioplasty later than 30 minutes from PCI hospital admission

Time: March April 2019 and 2020

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Description: In-Hospital mortality

Measure: In-hospital mortality

Time: March April 2019 and 2020

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Primary Outcomes

Description: Myocardtitis diagnosis in patients COVID+ and troponin+

Measure: characterize the myocardial damage associated with CoV-2 SARS infection

Time: Through study completion, an average of 1 year

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Primary Outcomes

Measure: Characterizing type 2 myocardial infarction associated with CoV-2 SARS infection

Time: Through study completion, an average of 1 year

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Primary Outcomes

Description: Frequency (%) of arterial or venous thromboembolism

Measure: Frequency of arterial or venous thromboembolism over 30 days

Time: 30 days

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Description: Frequency (%) of arterial or venous thromboembolism

Measure: Frequency of arterial or venous thromboembolism over 90 days

Time: 90 days

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Secondary Outcomes

Description: Frequency (%) of all-cause death, bleeding, and thromboembolic outcomes

Measure: Frequency of all-cause death, bleeding, and thromboembolic outcomes at 30 days

Time: 30 days

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Description: Frequency (%) of all-cause death, bleeding, and thromboembolic outcomes

Measure: Frequency of all-cause death, bleeding, and thromboembolic outcomes at 90 days

Time: 90 days

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Primary Outcomes

Description: Daily number of admissions for acute cardio- and neurivascular conditions in France.

Measure: Daily number of admissions for acute cardio- and neurivascular conditions in France.

Time: 1 day

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Secondary Outcomes

Description: Specific mortality rate.

Measure: Specific mortality rate.

Time: 1 day

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Primary Outcomes

Description: Device Oriented Clinical Endpoint (DOCE) of target lesion failure (TLF; cardiovascular death, target vessel myocardial infarction (TV-MI), or ischemia-driven target lesion revascularization (ID-TLR))

Measure: Target Lesion Failure (TLF)

Time: 1 year

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Secondary Outcomes

Description: Lesion-Level Analysis

Measure: Device Success

Time: During Study Procedure

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Description: Patient-Level Analysis

Measure: Procedural Success

Time: In-Hospital, assessed up to 7 days

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Description: Composite Device Oriented Clinical Endpoint (DOCE) (TLF; cardiovascular death, TV-MI, ischemia-driven TLR)

Measure: Composite Rate of Device Oriented Clinical Endpoint (DOCE)

Time: 30 days, 6 months, 1-5 years

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Description: Composite Patient Oriented Clinical Endpoint (POCE) (all-cause mortality, any stroke, any myocardial infarction (includes non-target vessel territory) and any revascularization). Note: Stroke to be collected and included in the POCE at 1 year and 5 years only.

Measure: Composite Rate of Patient Oriented Clinical Endpoint (POCE)

Time: 30 days, 6 months, 1-5 years

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Description: Target vessel failure (TVF; cardiovascular death, target vessel myocardial infarction (TV-MI), or target vessel revascularization (TVR))

Measure: Rate of Target Vessel Failure (TVF)

Time: 30 days, 6 months, 1-5 years

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Description: Composite of cardiovascular death, any myocardial infarction and any revascularization

Measure: Composite Rate of cardiovascular death, any myocardial infarction and any revascularization

Time: 30 days, 6 months, 1-5 years

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Description: Ischemia driven target lesion revascularization (ID-TLR)

Measure: Rate of Ischemia driven target lesion revascularization (ID-TLR)

Time: 30 days, 6 months, 1-5 years

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Description: All Target Lesion Revascularization

Measure: Rate of Target Lesion Revascularization (TLR)

Time: 30 days, 6 months, 1-5 years

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Description: All Target Vessel Revascularization

Measure: Rate of Target Vessel Revascularization (TVR)

Time: 30 days, 6 months, 1-5 years

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Description: Ischemia driven target vessel revascularization (ID-TVR)

Measure: Rate of Ischemia driven target vessel revascularization (ID-TVR)

Time: 30 days, 6 months, 1-5 years

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Description: Ischemia driven non target vessel revascularization (ID-NTVR)

Measure: Rate of Ischemia driven non target vessel revascularization (ID-NTVR)

Time: 30 days, 6 months, 1-5 years

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Description: Non target vessel revascularization (NTVR)

Measure: Rate of Non target vessel revascularization (NTVR)

Time: 30 days, 6 months, 1-5 years

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Description: All revascularization

Measure: Rate of All revascularization

Time: 30 days, 6 months, 1-5 years

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Description: All MI, Q-Wave and Non Q-Wave MI, TV-MI, NTV-MI

Measure: Rate of Myocardial Infarction

Time: 30 days, 6 months, 1-5 years

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Description: Cardiovascular Death, All-Cause Death

Measure: Rate of Death

Time: 30 days, 6 months, 1-5 years

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Description: Composite: Cardiovascular death or myocardial infarction

Measure: Composite: Cardiovascular death or myocardial infarction

Time: 30 days, 6 months, 1-5 years

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Description: Composite: All-cause death or myocardial infarction

Measure: Composite: All-cause death or myocardial infarction

Time: 30 days, 6 months, 1-5 years

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Description: Composite: All-cause death, myocardial infarction or target vessel revascularization

Measure: Composite: All-cause death, myocardial infarction or target vessel revascularization

Time: 30 days, 6 months, 1-5 years

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Description: Any stroke (collected at 1 year and 5 years only)

Measure: Rate of any stroke

Time: 1 year and 5 years

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Description: Anginal Status by Seattle Angina Questionnaire-7 (SAQ-7)

Measure: Anginal Status

Time: 30 days and 1 year

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Description: Composite: Probable or definite stent thrombosis Probable Stent Thrombosis Definite Stent Thrombosis

Measure: Rate of Stent Thrombosis

Time: 30 days, 6 months, 1-5 years

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Primary Outcomes

Description: Composite of all-cause death, amputation, and TLR will be assessed among the patients who receive XIENCE BTK and its competitors.

Measure: Number of participants with composite of all-cause death, amputation, and TLR

Time: During procedure (from the time a guide wire enters the vasculature till the patient leaves cath lab/procedure room)

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Description: Composite of all-cause death, amputation, and TLR will be assessed among the patients who receive XIENCE BTK and its competitors.

Measure: Number of participants with composite of all-cause death, amputation, and TLR

Time: 30 days

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Description: Composite of all-cause death, amputation, and TLR will be assessed among the patients who receive XIENCE BTK and its competitors.

Measure: Number of participants with composite of all-cause death, amputation, and TLR

Time: 12 months

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Description: Composite of all-cause death, amputation, TLR, target lesion occlusion will be assessed among the patients who receive Absolute Pro LongLength (LL), Supera 7.5 Outer Diameter (OD), Xpert Pro and its competitors.

Measure: Number of participants with composite of all-cause death, amputation, TLR, target lesion occlusion

Time: During procedure (from the time a guide wire enters the vasculature till the patient leaves cath lab/procedure room)

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Description: Composite of all-cause death, amputation, TLR, target lesion occlusion will be assessed among the patients who receive Absolute Pro LongLength (LL), Supera 7.5 Outer Diameter (OD), Xpert Pro and its competitors.

Measure: Number of participants with composite of all-cause death, amputation, TLR, target lesion occlusion

Time: 30 days

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Description: Composite of all-cause death, amputation, TLR, target lesion occlusion will be assessed among the patients who receive Absolute Pro LongLength (LL), Supera 7.5 Outer Diameter (OD), Xpert Pro and its competitors.

Measure: Number of participants with composite of all-cause death, amputation, TLR, target lesion occlusion

Time: 12 months

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Description: Composite of potential complications including implant success, occlusion success, migration will be assessed among the patients who receive AVP or AVP II or AVP 4 and its competitors.

Measure: Number of participants with composite of potential complications (Implant success, occlusion success,migration)

Time: During procedure (from the time a guide wire enters the vasculature till the patient leaves cath lab/procedure room)

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Description: Composite of occlusion success and migration will be assessed among the patients who receive AVP or AVP II or AVP 4 and its competitors.

Measure: Number of participants with composite of occlusion success and migration

Time: 30 days

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Description: Composite of vessel dissection, perforation, and thromboembolism during procedure will be assessed among the patients who receive PressureWire X and its competitors.

Measure: Number of participants with composite of vessel dissection, perforation, and thromboembolism

Time: During procedure (from the time a guide wire enters the vasculature till the patient leaves cath lab/procedure room)

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Description: Signal drift (Signal drift between measurements (Pd/Pa** pressure drift >0.03; <0.97 or >1.03) will be assessed among the patients who receive PressureWire X and its competitors.

Measure: Number of participants with signal drift (Signal drift between measurements (Pd/Pa** pressure drift >0.03; <0.97 or >1.03)

Time: During procedure (from the time a guide wire enters the vasculature till the patient leaves cath lab/procedure room)

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Description: Loss of capture (average time of loss of capture across patients) will be assessed among the patients who receive Pacel FDPC and its competitors.

Measure: Loss of capture

Time: During procedure (from the time a guide wire enters the vasculature till the patient leaves cath lab/procedure room)

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Description: Composite of potential complications (venous thrombosis, pulmonary emboli, arrhythmias, perforation) will be assessed among the patientswho receive Pacel BPC and its competitors.

Measure: Number of participants with composite of potential complications (venous thrombosis, pulmonary emboli, arrhythmias, perforation)

Time: During procedure (from the time a guide wire enters the vasculature till the patient leaves cath lab/procedure room)

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Description: Composite of all-cause death, MI or target lesion revascularization(TLR) will be assessed among the patients who receive MULTI-LINK 8or MULTI-LINK 8 LL or MULTI-LINK 8 SV and its competitors.

Measure: Number of participants with composite of all-cause death, MI or target lesion revascularization (TLR)

Time: During procedure (from the time a guide wire enters the vasculature till the patient leaves cath lab/procedure room)

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Description: Composite of all-cause death, MI or target lesion revascularization(TLR) will be assessed among the patients who receive MULTI-LINK 8or MULTI-LINK 8 LL or MULTI-LINK 8 SV and its competitors.

Measure: Number of participants with composite of all-cause death, MI or target lesion revascularization (TLR)

Time: 30 days

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Description: Composite of all-cause death, MI or target lesion revascularization(TLR) will be assessed among the patients who receive MULTI-LINK 8or MULTI-LINK 8 LL or MULTI-LINK 8 SV and its competitors.

Measure: Number of participants with composite of all-cause death, MI or target lesion revascularization (TLR)

Time: 12 months

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Primary Outcomes

Description: Composite of all-cause death, amputation, and TLR will be assessed among the patients who receive XIENCE BTK and its competitors.

Measure: Number of participants with composite of all-cause death, amputation, and TLR

Time: During procedure (from the time a guide wire enters the vasculature till the patient leaves cath lab/procedure room)

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Description: Composite of all-cause death, amputation, and TLR will be assessed among the patients who receive XIENCE BTK and its competitors.

Measure: Number of participants with composite of all-cause death, amputation, and TLR

Time: 30 days

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Description: Composite of all-cause death, amputation, and TLR will be assessed among the patients who receive XIENCE BTK and its competitors.

Measure: Number of participants with composite of all-cause death, amputation, and TLR

Time: 12 months

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Description: Composite of all-cause death, amputation, TLR, target lesion occlusion will be assessed among the patients who receive Absolute Pro LongLength (LL), Supera 7.5 Outer Diameter (OD), Xpert Pro and its competitors.

Measure: Number of participants with composite of all-cause death, amputation, TLR, target lesion occlusion

Time: During procedure (from the time a guide wire enters the vasculature till the patient leaves cath lab/procedure room)

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Description: Composite of all-cause death, amputation, TLR, target lesion occlusion will be assessed among the patients who receive Absolute Pro LongLength (LL), Supera 7.5 Outer Diameter (OD), Xpert Pro and its competitors.

Measure: Number of participants with composite of all-cause death, amputation, TLR, target lesion occlusion

Time: 30 days

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Description: Composite of all-cause death, amputation, TLR, target lesion occlusion will be assessed among the patients who receive Absolute Pro LongLength (LL), Supera 7.5 Outer Diameter (OD), Xpert Pro and its competitors.

Measure: Number of participants with composite of all-cause death, amputation, TLR, target lesion occlusion

Time: 12 months

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Description: Composite of potential complications including implant success, occlusion success, migration will be assessed among the patients who receive AVP or AVP II or AVP 4 and its competitors.

Measure: Number of participants with composite of potential complications (Implant success, occlusion success,migration)

Time: During procedure (from the time a guide wire enters the vasculature till the patient leaves cath lab/procedure room)

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Description: Composite of occlusion success and migration will be assessed among the patients who receive AVP or AVP II or AVP 4 and its competitors.

Measure: Number of participants with composite of occlusion success and migration

Time: 30 days

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Description: Composite of vessel dissection, perforation, and thromboembolism during procedure will be assessed among the patients who receive PressureWire X and its competitors.

Measure: Number of participants with composite of vessel dissection, perforation, and thromboembolism

Time: During procedure (from the time a guide wire enters the vasculature till the patient leaves cath lab/procedure room)

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Description: Signal drift (Signal drift between measurements (Pd/Pa** pressure drift >0.03; <0.97 or >1.03) will be assessed among the patients who receive PressureWire X and its competitors.

Measure: Number of participants with signal drift (Signal drift between measurements (Pd/Pa** pressure drift >0.03; <0.97 or >1.03)

Time: During procedure (from the time a guide wire enters the vasculature till the patient leaves cath lab/procedure room)

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Description: Loss of capture (average time of loss of capture across patients) will be assessed among the patients who receive Pacel FDPC and its competitors.

Measure: Loss of capture

Time: During procedure (from the time a guide wire enters the vasculature till the patient leaves cath lab/procedure room)

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Description: Composite of potential complications (venous thrombosis, pulmonary emboli, arrhythmias, perforation) will be assessed among the patientswho receive Pacel BPC and its competitors.

Measure: Number of participants with composite of potential complications (venous thrombosis, pulmonary emboli, arrhythmias, perforation)

Time: During procedure (from the time a guide wire enters the vasculature till the patient leaves cath lab/procedure room)

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Description: Composite of all-cause death, MI or target lesion revascularization(TLR) will be assessed among the patients who receive MULTI-LINK 8or MULTI-LINK 8 LL or MULTI-LINK 8 SV and its competitors.

Measure: Number of participants with composite of all-cause death, MI or target lesion revascularization (TLR)

Time: During procedure (from the time a guide wire enters the vasculature till the patient leaves cath lab/procedure room)

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Description: Composite of all-cause death, MI or target lesion revascularization(TLR) will be assessed among the patients who receive MULTI-LINK 8or MULTI-LINK 8 LL or MULTI-LINK 8 SV and its competitors.

Measure: Number of participants with composite of all-cause death, MI or target lesion revascularization (TLR)

Time: 30 days

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Description: Composite of all-cause death, MI or target lesion revascularization(TLR) will be assessed among the patients who receive MULTI-LINK 8or MULTI-LINK 8 LL or MULTI-LINK 8 SV and its competitors.

Measure: Number of participants with composite of all-cause death, MI or target lesion revascularization (TLR)

Time: 12 months

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Primary Outcomes

Description: Distribution and Extent of myocardial injury in COVID 19 patients presented with myocardial infarction and non COVID Patients presented with myocardial infarction evaluated with CMR.

Measure: comparison between COVID-19 and COVID-19 presented with myocardial infarction

Time: baseline

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Primary Outcomes

Description: Measure of cardiac anxiety, fear, avoidance and attention. The score ranges between 0 and 72, with a greater score indicating elevated cardiac anxiety.

Measure: Cardiac anxiety questionnaire

Time: baseline

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Description: Measure of cardiac anxiety, fear, avoidance and attention. The score ranges between 0 and 72, with a greater score indicating elevated cardiac anxiety.

Measure: Cardiac anxiety questionnaire

Time: 2 months from baseline

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Description: Measure of cardiac anxiety, fear, avoidance and attention. The score ranges between 0 and 72, with a greater score indicating elevated cardiac anxiety.

Measure: Cardiac anxiety questionnaire

Time: 8 months from baseline

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Secondary Outcomes

Description: General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life.

Measure: 12-Item Short-Form Health Survey (SF-12)

Time: Baseline

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Description: General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life.

Measure: 12-Item Short-Form Health Survey (SF-12)

Time: 2 months from baseline

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Description: General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life.

Measure: 12-Item Short-Form Health Survey (SF-12)

Time: 8 months from baseline

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Description: Fear of bodily symptoms, score ranging from 0 to 72 . Higher scores indicate more fear of body sensations.

Measure: Body Sensation Questionnaire

Time: Baseline

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Description: Fear of bodily symptoms, score ranging from 0 to 72 . Higher scores indicate more fear of body sensations.

Measure: Body Sensation Questionnaire

Time: 2 months from baseline

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Description: Fear of bodily symptoms, score ranging from 0 to 72 . Higher scores indicate more fear of body sensations.

Measure: Body Sensation Questionnaire

Time: 8 months from baseline

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Description: Measure of depression, score ranging 0 to 27 with a higher score indicating higher level of depression.

Measure: Patient Health Questionnaire-9

Time: Baseline

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Description: Measure of depression, score ranging 0 to 27 with a higher score indicating higher level of depression.

Measure: Patient Health Questionnaire-9

Time: 2 months from Baseline

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Description: Measure of depression, score ranging 0 to 27 with a higher score indicating higher level of depression.

Measure: Patient Health Questionnaire-9

Time: 8 months from Baseline

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Description: General anxiety, score ranging from 0-21, with a higher score indicating more anxiety and worry.

Measure: Generalized Anxiety Disorder 7-item

Time: Baseline

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Description: General anxiety, score ranging from 0-21, with a higher score indicating more anxiety and worry.

Measure: Generalized Anxiety Disorder 7-item

Time: 2 months from baseline

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Description: General anxiety, score ranging from 0-21, with a higher score indicating more anxiety and worry.

Measure: Generalized Anxiety Disorder 7-item

Time: 8 months from baseline

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Description: Level of physical activity. The participant rate numbers of time per week that they engage in physical activity. The numb ers are the categorized in to low, moderate, and high levels of physical activity.

Measure: The Godin Leisure-time Exercise

Time: Baseline

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Description: Level of physical activity. The participant rate numbers of time per week that they engage in physical activity. The numb ers are the categorized in to low, moderate, and high levels of physical activity.

Measure: The Godin Leisure-time Exercise

Time: 2 months from Baseline

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Description: Level of physical activity. The participant rate numbers of time per week that they engage in physical activity. The numb ers are the categorized in to low, moderate, and high levels of physical activity.

Measure: The Godin Leisure-time Exercise

Time: 8 months from Baseline

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Description: Fear of physical activity. The total score varies between 17 and 68, with higher values indicating more severe kinesiophobia.

Measure: Tampas Scale for Kinesophobia-Heart version

Time: Baseline

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Description: Fear of physical activity. The total score varies between 17 and 68, with higher values indicating more severe kinesiophobia.

Measure: Tampas Scale for Kinesophobia-Heart version

Time: 2 months from Baseline

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Description: Fear of physical activity. The total score varies between 17 and 68, with higher values indicating more severe kinesiophobia.

Measure: Tampas Scale for Kinesophobia-Heart version

Time: 8 months form Baseline

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Description: Treatment satisfaction, score ranging from 0 to 32, with a higher score indication more satisfaction with the treatment.

Measure: Client satisfaction Questionnaire

Time: 2 months from Baseline

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Description: Potential adverse reactions to the treatment. Participants will be asked to report and rate the short- and long term discomfort of the adverse event on a scale from 0 ('did not affect me at all') and 3 ('affected me very negatively').

Measure: Adverse events

Time: 2 months from baseline

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Description: Potential adverse reactions to the treatment. Participants will be asked to report and rate the short- and long term discomfort of the adverse event on a scale from 0 ('did not affect me at all') and 3 ('affected me very negatively').

Measure: Adverse events

Time: 8 months from baseline

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