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

---

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

---

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

---

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

---

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

---

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

---

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

---

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

---

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

---

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

---

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

---

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

---

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

---

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

---

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

---

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

---

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

---

Primary Outcomes

Description: Mean minutes/day moderate to vigorous physical activity

Measure: ActiGraph GT9X Link Accelerometer

Time: Month 12

---

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

---

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

---

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

---

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

---

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

---

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

---

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

Measure: PROMIS-29

Time: Month 12

---

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

---

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

---

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

---

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

---

Primary Outcomes

Description: Species count in fecal sample

Measure: Gut microbiome species richness

Time: 1 Day

---

Description: Measurement of blood lipids

Measure: Lipids

Time: 3 days

---

Description: Measurement of blood glucose

Measure: Glucose

Time: 11 days

---

Description: Record of sleep pattern using a wearable device (i.e. fitness watch)

Measure: Sleep

Time: 10 days

---

Description: Record of physical activity using a wearable device (i.e. fitness watch)

Measure: Physical activity

Time: 10 days

---

Description: Record of hunger and appetite patterns using a digital app

Measure: Hunger and appetite assessment

Time: 10 days

---

Secondary Outcomes

Description: C-peptide

Measure: Glucose metabolism

Time: 3 days

---

Description: Weighed food log

Measure: Dietary assessment

Time: 10 days

---

Description: Weight (kg)

Measure: Anthropometry

Time: 1 day

---

Description: Height (cm)

Measure: Anthropometry

Time: 1 day

---

Description: Hip and waist circumference (cm)

Measure: Anthropometry

Time: 1 day

---

Description: Lipoprotein concentration (mol/L), lipoprotein composition (mol/L), glycoprotein acetyl concentration (mol/L), ketone bodies concentration (mol/L)

Measure: Metabolomics by NMR analysis

Time: 1 day

---

Description: Diet history and portion size questionnaire about the preceding month, using the Diet History Questionnaire 3 from National Cancer Institute.

Measure: Dietary assessment

Time: 1 month

---

Description: Self-reported demographic and physical health symptoms, or lack thereof, reported on a daily basis.

Measure: Covid-19 symptom assessment

Time: 6 months

---

Other Outcomes

Description: Self-reported in-app question on daily frequency of adherence (categorical)

Measure: Adherence (in sub-cohort)

Time: 12 months: Baseline, Weekly (0 to 4 weeks), monthly (5 to 52 weeks)

---

Description: Self-reported in-app question on hunger levels (categorical)

Measure: Hunger (in sub-cohort)

Time: 12 months: Baseline, Weekly (0 to 4 weeks), monthly (5 to 52 weeks)

---

Description: Self-reported in-app question on weight (lbs)

Measure: Weight (in sub-cohort)

Time: 12 months: Baseline, Weekly (0 to 4 weeks), monthly (5 to 52 weeks)

---

Description: Self-reported in-app Bristol Stool chart questoin (categorical)

Measure: Bristol Stool Category (in sub-cohort)

Time: 12 months: Baseline, Weekly (0 to 4 weeks), monthly (5 to 52 weeks)

---

Description: Self-reported in-app question on bowel frequency

Measure: Bowel Frequency (in sub-cohort)

Time: 12 months: Baseline, Weekly (0 to 4 weeks), monthly (5 to 52 weeks)

---

Description: Self-reported in-app question on energy levels (categorical)

Measure: Energy (in sub-cohort)

Time: 12 months: Baseline, Weekly (0 to 4 weeks), monthly (5 to 52 weeks)

---

Description: Self-reported in-app question on alertness (categorical)

Measure: Alertness (in sub-cohort)

Time: 12 months: Baseline, Weekly (0 to 4 weeks), monthly (5 to 52 weeks)

---

Description: Self-reported in-app question on stress (categorical)

Measure: Stress (in sub-cohort)

Time: 12 months: Baseline, Weekly (0 to 4 weeks), monthly (5 to 52 weeks)

---

Description: Self-reported in-app question on mood (categorical)

Measure: Mood (in sub-cohort)

Time: 12 months: Baseline, Weekly (0 to 4 weeks), monthly (5 to 52 weeks)

---

Description: Self-reported in-app question on daily frequency of activity (categorical)

Measure: Activity (in sub-cohort)

Time: 12 months: Baseline, Weekly (0 to 4 weeks), monthly (5 to 52 weeks)

---

Primary Outcomes

Description: Inhibition of Platelet Aggregation

Measure: Platelet Inhibition

Time: Baseline

---

Description: Inhibition of Platelet aggregation

Measure: Platelet Inhibition

Time: 15 minutes

---

Description: Inhibition of Platelet aggregation

Measure: Platelet inhibition

Time: 45 minutes

---

Description: Inhibition of Platelet aggregation

Measure: Platelet inhibition

Time: 60 minutes

---

Description: Inhibition of Platelet aggregation

Measure: Platelet inhibition

Time: 90 minutes

---

Description: Inhibition of Platelet aggregation

Measure: Platelet inhibition

Time: 120 minutes

---

Description: Inhibition of Platelet aggregation

Measure: Platelet inhibition

Time: 180 minutes

---

Description: concentration in blood (ng/mL)

Measure: RUC-4 Concentration

Time: Baseline

---

Description: concentration in blood (ng/mL)

Measure: RUC-4 Concentration

Time: 15 minutes

---

Description: concentration in blood (ng/mL)

Measure: RUC-4 Concentration

Time: 45 minutes

---

Description: concentration in blood (ng/mL)

Measure: RUC-4 Concentration

Time: 90 minutes

---

Description: concentration in blood (ng/mL)

Measure: RUC-4 Concentration

Time: 120 minutes

---

Description: concentration in blood (ng/mL)

Measure: RUC-4 Concentration

Time: 180 minutes

---

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

Measure: Safety and Tolerability

Time: Baseline

---

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

Measure: Safety and Tolerability

Time: Hospital discharge

---

Description: concentration in blood (ng/mL)

Measure: RUC-4 Concentration

Time: 240 minutes

---

Description: Inhibition of platelet aggregation

Measure: Platelet aggregation

Time: 240 minutes

---

Primary Outcomes

Description: Prevalence of Covid-19 infection in the overall CHD population

Measure: Prevalence of Covid-19 infection in the overall CHD population

Time: through study completion, an average of 2 weeks

---

Secondary Outcomes

Description: Prevalence of Covid-19 infection per CHD sub-group

Measure: Prevalence of Covid-19 infection per CHD sub-group

Time: through study completion, an average of 2 weeks

---

Description: Cardiovascular complications

Measure: Cardiovascular complications

Time: through study completion, an average of 2 weeks

---

Description: Other complications

Measure: Other complications

Time: through study completion, an average of 2 weeks

---

Description: Number of deaths

Measure: Number of deaths

Time: through study completion, an average of 2 weeks

---

Primary Outcomes

Description: This is set on visit 3 (90 ± 5 days from the date of visit 1). The two groups of vaccination are compared for the primary endpoints which is composite. Patients who meet any of the following will be considered to meet the primary endpoint: Positive for the respiratory questionnaire endpoint when at least one of the following combination is met either at visit 2 and/or at visit 3: One situation definitively related to COVID-19 All four questions of symptoms possibly related to COVID-19 At least two questions of symptoms possibly related to COVID-19 as well as need for admission at the emergency department of any hospital and/or need for intake of antibiotics At least four questions of symptoms probably related to COVID-19 one of which is "need for admission at the emergency department of any hospital and/or need for intake of antibiotics" Positive IgG or IgM antibodies against SARS-CoV-2

Measure: Positive for the respiratory questionnaire consisted of questions concerning the appearance of symptoms possibly, probably and/or definitively related to COVID-19 on visit 3.

Time: Visit 3 (90 +/- 5 days)

---

Secondary Outcomes

Description: The two groups of vaccination are compared for the primary endpoints which is composite (as defined at primary study endpoint) and meet a positive respiratory questionnaire endpoint on visit 4

Measure: Positive respiratory questionnaire endpoint consisted of questions concerning the appearance of symptoms possibly, probably and/or definitively related to COVID-19 on visit 4

Time: Visit 4 (135 +/- 5 days)

---

Description: The two groups of vaccination are compared for the primary endpoints which is composite (as defined at primary study endpoint) and meet a positive respiratory questionnaire endpoint (as defined at primary study endpoint) on visit 5

Measure: Positive respiratory questionnaire endpoint consisted of questions concerning the appearance of symptoms possibly, probably and/or definitively related to COVID-19 on visit 5

Time: Visit 5 (180 +/- 5 days)

---

Description: Prevalence of IgG/IgM against SARS-CoV-2 will be measured among the patients who failed the eligibility procedure and the patients that were eligible and were enrolled

Measure: Prevalence of IgG/IgM against SARS-CoV-2

Time: Screening Visit and Visit 3 (90 +/- 5 days)

---

Description: Itemized analysis of each of the components of the respiratory questionnaire on each study visit

Measure: Analysis of each of the components of the respiratory questionnaire consisted of questions concerning the appearance of symptoms possibly, probably and/or definitively related to COVID-19.

Time: Visit 2 (45 +/- 5 days), Visit 3 (90 +/- 5 days), Visit 4 (135 +/- 5 days), Visit 5 (180 +/- 5 days)

---

Description: The impact of new cardiovascular events between the two study groups (placebo and BCG) will be analyzed, though the collection of any cardiovascular events occured to the enrolled patients.

Measure: The impact of new cardiovascular events between the two study groups

Time: Visit 2 (45 +/- 5 days), Visit 3 (90 +/- 5 days), Visit 4 (135 +/- 5 days), Visit 5 (180 +/- 5 days)

---

Description: Differences in repeated measurements of arterial stiffness in visit 3 between the two sub-study groups (placebo or BCG) will be analyzed through the speed of the pulse wave velocity. Pulse wave velocity is measured in m/sec.

Measure: Differences in repeated measurements of angiometric parameters (arterial hardness) between the two sub-study groups in Visit 3

Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days)

---

Description: Differences in repeated measurements of central arterial pressures and reflected waves in visit 3 between the two sub-study groups (placebo or BCG) will be measured non-invasively by pulse wave analysis. Central arterial pressure is measured in mmHg.

Measure: Differences in repeated measurements of angiometric parameters (central arterial pressures and reflected waves) between the two sub-study groups in Visit 3

Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days)

---

Description: Differences in repeated measurements of endothelial function in visit 3 between the two sub-study groups (placebo or BCG) will be measured by ultrasound measurement of endothelium-dependent flow-mediated dilatation and by nitrate-mediated dialatation. Endothelial function will be assessed by Flow Mediated Dilatation (FMD). Endothelium-dependent: diameter of the artery prior and after temporary ischemia in is measured in mm, nitrate-mediated: diameter of the artery prior and after nitrate administration is measured in mm

Measure: Differences in repeated measurements of angiometric parameters (endothelial function) between the two sub-study groups in Visit 3

Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days)

---

Description: Differences in repeated measurements of thickness of the medial carotid sheath in visit 3 between the two sub-study groups (placebo or BCG) will be measured by B-mode ultrasound examination. Intima-Media Thickness is measured in mm

Measure: Differences in repeated measurements of angiometric parameters (thickness of the medial carotid sheath) between the two sub-study groups in Visit 3

Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days)

---

Description: Differences in repeated measurements of arterial stiffness in visit 5 between the two sub-study groups (placebo or BCG) will be analyzed through the speed of the pulse wave velocity. Pulse wave velocity is measured in m/sec.

Measure: Differences in repeated measurements of angiometric parameters (arterial hardness) between the two sub-study groups in Visit 5

Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days), Visit 5 (180 +/- 5 days)

---

Description: Differences in repeated measurements of central arterial pressures and reflected waves in visit 5 between the two sub-study groups (placebo or BCG) will be measured non-invasively by pulse wave analysis. Central arterial pressure is measured in mmHg.

Measure: Differences in repeated measurements of angiometric parameters (central arterial pressures and reflected waves) between the two sub-study groups in Visit 5

Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days), Visit 5 (180 +/- 5 days)

---

Description: Differences in repeated measurements of thickness of the medial carotid sheath in visit 5 between the two sub-study groups (placebo or BCG) will be measured by B-mode ultrasound examination. Intima-Media Thickness is measured in mm

Measure: Differences in repeated measurements of angiometric parameters (thickness of the medial carotid sheath) between the two sub-study groups in Visit 5

Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days), Visit 5 (180 +/- 5 days)

---

Description: Differences in repeated measurements of endothelial function in visit 5 between the two sub-study groups (placebo or BCG) will be measured by ultrasound measurement of endothelium-dependent flow-mediated dilatation and by nitrate-mediated dialatation. Endothelial function will be assessed by Flow Mediated Dilatation (FMD). Endothelium-dependent: diameter of the artery prior and after temporary ischemia in is measured in mm, nitrate-mediated: diameter of the artery prior and after nitrate administration is measured in mm

Measure: Differences in repeated measurements of angiometric parameters (endothelial function) between the two sub-study groups in Visit 5

Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days), Visit 5 (180 +/- 5 days)

---

Description: Differences in cardiac ultrasound at visit 5 between the two sub-study groups (placebo or BCG) will be assessed using standard measurements from 2-D and Doppler echocardiography.

Measure: Differences in cardiac ultrasound at visit 5 between the two sub-study groups

Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days), Visit 5 (180 +/- 5 days)

---

Description: Changes in the release of cytokines from blood mononuclear cells at visit 3 between the two sub-study groups (placebo or BCG) will be analyzed

Measure: Changes in the release of cytokines from blood mononuclear cells at visit 3 between the two sub-study groups

Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days)

---

Primary Outcomes

Description: Identify organ dysfunction after SARS-CoV-2 infections

Measure: Sequelae after COVID-19

Time: 12 months, extension if required

---

Primary Outcomes

Description: Accuracy of rPPG heart rate compared to conventional vital sign monitor heart rate readings. Comparison of each paired reading.

Measure: Accuracy of rPPG heart rate

Time: immediate; paired reading

---

Description: Accuracy of rPPG oxygen saturation compared to conventional vital sign monitor oxygen saturation readings. Comparison of discrepancy within each paired reading set.

Measure: Accuracy of rPPG oxygen saturation

Time: immediate; paired reading

---

Description: Accuracy of rPPG respiratory rate compared to manual counting of respiratory rate over 60 seconds. Comparison of discrepancy within each paired reading set.

Measure: Accuracy of rPPG respiratory rate

Time: immediate; paired reading

---

Secondary Outcomes

Description: Comparison of rPPG heart rate results obtained on a given patient on serial readings within 2 minutes of each other.

Measure: Reproducibility of rPPG heart rate readings

Time: 2-5 minutes

---

Description: Comparison of rPPG oxygen saturation results obtained on a given patient on serial readings within 2 minutes of each other.

Measure: Reproducibility of rPPG oxygen saturation readings

Time: 2-5 minutes

---

Description: Comparison of rPPG respiratory rate results obtained on a given patient on serial readings within 2 minutes of each other.

Measure: Reproducibility of rPPG respiratory rate readings

Time: 2-5 minutes

---

Other Outcomes

Description: Analysis of accuracy of rPPG vital sign readings when stratified by oxygen saturation per conventional monitors stratified as follows: 95-100%; 90-94%; 85-89%; Less than 85%

Measure: Accuracy of rPPG readings by oxygen saturation level

Time: immediate; stratified analysis

---

Description: Analysis of accuracy of rPPG vital sign readings when stratified by skin colour per the Fitzpatrick scale

Measure: Accuracy of rPPG readings by skin colour

Time: immediate; stratified analysis

---

Description: Analysis of accuracy of rPPG vital sign readings when stratified for gender

Measure: Accuracy of rPPG readings by gender

Time: immediate; stratified analysis

---

Description: Analysis of accuracy of rPPG vital sign readings when stratified by age group

Measure: Accuracy of rPPG readings by age

Time: immediate; stratified analysis

---

Description: Analysis of accuracy of rPPG vital sign readings when stratified for COVID, respiratory conditions, cardiac conditions and vascular conditions.

Measure: Accuracy of rPPG readings by comorbidity

Time: immediate; stratified analysis

---

Primary Outcomes

Description: percentage of patients with non-infectious diseases relating to overall number of patients registered in study

Measure: rate of non-infectious diseases

Time: 12 month since a moment of request of medical help

---

Description: correlation between number of patients with COVID-19 of various severity and number of pre-existing conditions and their severity among these groups

Measure: severity of COVID-19 depending on pre-existing diseases

Time: 12 month since a moment of request of medical help

---

Description: Registration of disability or change of disability status

Measure: disability registration / change of disability status

Time: 12 month since a moment of request of medical help

---

Description: rate of deaths among registered participants

Measure: rate of letal outcomes

Time: 12 month since a moment of request of medical help

---

Description: correlation between number of deaths and pre-existing diseases

Measure: rate of letal outcomes depending on pre-existing disease

Time: 12 month since a moment of request of medical help

---

Primary Outcomes

Description: The primary endpoint Net Adverse Clinical Endpoints (NACE) defined as a composite of cardiovascular death, myocardial infarction, target vessel revascularization, stroke and bleeding events defined as BARC 3 or 5 at 12 months follow-up after the index PCI.

Measure: Net Adverse Clinical Endpoints (NACE)

Time: 1 year

---

Secondary Outcomes

Description: Major adverse cardiac and cerebral events (MACCE) defined as a composite of cardiac death, myocardial infarction, target vessel revascularization and stroke

Measure: Major adverse cardiac and cerebral events (MACCE)

Time: 1 year

---

Description: Major or clinically relevant non-major bleeding (MCB) defined as a composite of type 2, 3 and 5 BARC bleeding events

Measure: Major or clinically relevant non-major bleeding (MCB)

Time: 1 year

---

Description: Target Lesion Failure (TLF) is defined as cardiac death, myocardial infarction attributed to the target vessel and clinically indicated target lesion revascularization

Measure: Target Lesion Failure (TLF)

Time: 1 year

---

Description: Target Vessel Failure (TVF) is defined as cardiac death, myocardial infarction attributed to the target vessel and clinically indicated target vessel revascularization

Measure: Target vessel failure (TVF)

Time: 1 year

---

Description: The composite endpoint of cardiovascular death, myocardial infarction and stroke

Measure: The composite of cardiovascular death, myocardial infarction and stroke

Time: 1 year

---

Description: The composite of cardiovascular death, myocardial infarction, stroke and major bleed according to BARC 3 and 5

Measure: The composite of cardiovascular death, myocardial infarction, stroke and major bleed BARC 3 and 5

Time: 1 year

---

Description: Stent thrombosis according to the ARC definitions

Measure: Stent thrombosis

Time: 1 year

---

Description: Myocardial infarction.

Measure: Myocardial infarction

Time: 1 year

---

Description: Urgent target vessel revascularization.

Measure: Urgent target vessel revascularization

Time: 1 year

---

Description: Non-target vessel revascularization.

Measure: Non-target vessel revascularization

Time: 1 year

---

Description: Clinically indicated target vessel revascularization.

Measure: Clinically indicated target vessel revascularization

Time: 1 year

---

Description: Bleeding events according to the BARC, TIMI and GUSTO classification

Measure: Bleeding events

Time: 1 year

---

Description: Transfusion rates both in patients with and/or without clinically detected over bleeding

Measure: Transfusion rates

Time: 1 year

---

Description: Event rates according to the PRECISE-DAPT score

Measure: Event rates according to the PRECISE-DAPT

Time: 1 year

---

Description: Procedural success is defined as angiographic success with no in-hospital MACE, defined as death, MI with new Q-waves on electrocardiogram (ECG) or urgent target vessel revascularization (TVR) (including both repeat PCI and coronary artery bypass graft surgery (CABG)

Measure: Procedural success

Time: At completion of the baseline PCI

---

Description: Device success (applying a lesion-level analysis)

Measure: Device success

Time: At discharge of baseline hospitalisation, on average 3 days

---

Primary Outcomes

Description: Number of days patient found to have delirium using the Confusion Assessment Method for the ICU (CAM-ICU)

Measure: Duration of delirium

Time: From the date of admission to the Intensive Care Unit (ICU) until discharge from the ICU or death, whichever came first, up to 12 months.

---

Secondary Outcomes

Description: CAM-ICU

Measure: Incidence of delirium

Time: From the date of admission to the Intensive Care Unit (ICU) until discharge from the ICU or death, whichever came first, up to 12 months.

---

Description: Days

Measure: Length of critical care stay

Time: From the date of admission to the ICU until discharge from the ICU or death, whichever came first, up to 12 months.

---

Description: Days

Measure: Length of hospital stay

Time: From the date of admission to the hospital until discharge from the hospital or death, whichever came first, up to 12 months.

---

Measure: Doses of specified drugs during ICU admission

Time: From the date of admission to the ICU until discharge from the ICU or death, whichever came first, up to 12 months.

---

Description: Days

Measure: Length of time ventilated

Time: From the date of admission to the ICU until discharge from the ICU or death, whichever came first, up to 12 months.

---

Measure: Mortality

Time: 6 months

---

Other Outcomes

Description: Semi structured interviews

Measure: Exploring the experiences of patients, relatives and staff of the visitation restrictions during the COVID-19 pandemic

Time: 18 months

---

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

---

Secondary Outcomes

Description: Lesion-Level Analysis

Measure: Device Success

Time: During Study Procedure

---

Description: Patient-Level Analysis

Measure: Procedural Success

Time: In-Hospital, assessed up to 7 days

---

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

---

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

---

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

---

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

---

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

---

Description: All Target Lesion Revascularization

Measure: Rate of Target Lesion Revascularization (TLR)

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

---

Description: All Target Vessel Revascularization

Measure: Rate of Target Vessel Revascularization (TVR)

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

---

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

---

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

---

Description: Non target vessel revascularization (NTVR)

Measure: Rate of Non target vessel revascularization (NTVR)

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

---

Description: All revascularization

Measure: Rate of All revascularization

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

---

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

---

Description: Cardiovascular Death, All-Cause Death

Measure: Rate of Death

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

---

Description: Composite: Cardiovascular death or myocardial infarction

Measure: Composite: Cardiovascular death or myocardial infarction

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

---

Description: Composite: All-cause death or myocardial infarction

Measure: Composite: All-cause death or myocardial infarction

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

---

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

---

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

Measure: Rate of any stroke

Time: 1 year and 5 years

---

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

Measure: Anginal Status

Time: 30 days and 1 year

---

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

---

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)

---

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

---

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

---

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)

---

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

---

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

---

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)

---

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

---

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)

---

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)

---

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)

---

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)

---

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)

---

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

---

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

---

Primary Outcomes

Description: This is a qualitative research study. The investigators are using a combination of Experience Group sessions, Contextual Interviews and workshops with patients and their family members to obtain information to identify areas of the lifelong journey of patient with single-ventricle congenital heart disease and their families that can be redesigned to improve the outcomes that matter most to the patients and their families

Measure: Identification of areas to be improved in patient and families' journey

Time: 2 years

---

Primary Outcomes

Description: Percentage of myocardium demonstrating late gadolinium enhancement by cardiac magnetic resonance (CMR) imaging, determined using Circle cvi42 software.

Measure: Percentage of myocardium demonstrating late gadolinium enhancement

Time: Up to 2 hours

---

Description: Extracellular volume fraction measured by CMR imaging. ECV determined using Circle cvi42 software and using formula ECV = (1-hematocrit) × (Δ(1/T1myocardium)/Δ(1/T1blood)).

Measure: Extracellular Volume (ECV) Fraction

Time: Up to 2 hours

---

Description: Left ventricular ejection fraction (percent ejection fraction) by CMR imaging and determined using Circle cvi42 software.

Measure: Left Ventricular Ejection Fraction

Time: Up to 2 hours

---