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D007511: Ischemia

Developed by Shray Alag, The Harker School
Sections: Correlations, Clinical Trials, and HPO

Correlations computed by analyzing all clinical trials.

Navigate: Clinical Trials and HPO


Correlated Drug Terms (12)


Name (Synonyms) Correlation
drug3417 Temsirolimus Wiki 0.41
drug179 Ad5FGF-4 Wiki 0.41
drug622 COVID 19 impact Wiki 0.41
Name (Synonyms) Correlation
drug2719 QFR Wiki 0.41
drug1139 ESPRIT™ BTK Device Wiki 0.41
drug2462 Percutaneous Transluminal Angioplasty (PTA) Device Wiki 0.41
drug3028 Saline placebo Wiki 0.41
drug1583 IC14 Wiki 0.41
drug427 BRII-198 Wiki 0.41
drug1986 Mechanical Trombectomy Wiki 0.41
drug243 Angiography Wiki 0.41
drug2505 Placebo Wiki 0.04

Correlated MeSH Terms (9)


Name (Synonyms) Correlation
D023921 Coronary Stenosis NIH 0.41
D060050 Angina, Stable NIH 0.41
D003324 Coronary Artery Disease NIH 0.31
Name (Synonyms) Correlation
D000787 Angina Pectoris NIH 0.29
D058729 Peripheral Arterial Disease NIH 0.24
D009203 Myocardial Ischemia NIH 0.20
D003327 Coronary Disease NIH 0.15
D020521 Stroke NIH 0.10
D004630 Emergencies NIH 0.07

Correlated HPO Terms (6)


Name (Synonyms) Correlation
HP:0005145 Coronary artery stenosis HPO 0.41
HP:0001677 Coronary artery atherosclerosis HPO 0.33
HP:0001681 Angina pectoris HPO 0.29
Name (Synonyms) Correlation
HP:0001658 Myocardial infarction HPO 0.22
HP:0004950 Peripheral arterial stenosis HPO 0.18
HP:0001297 Stroke HPO 0.11

Clinical Trials

Navigate: Correlations   HPO

There are 6 clinical trials


1 A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter, Phase 3 Study to Evaluate the Safety and Efficacy of Ad5FGF-4 in Patients With Refractory Angina Due to Myocardial Ischemia

The purpose of this study is to determine whether a single intracoronary infusion of an adenovirus serotype 5 virus expressing the gene for human fibroblast growth factor-4 (Ad5FGF-4) is effective in improving angina-limited exercise duration, angina functional class, frequency of angina attacks, frequency of nitroglycerin usage, and quality of life. Half of the study participants will receive Ad5FGF-4, and half will receive placebo. The primary endpoint is the change from baseline to Month 6 in Exercise Tolerance Test (ETT) duration. Long-term safety of Ad5FGF-4 will also be assessed.

NCT02928094
Conditions
  1. Angina, Stable
Interventions
  1. Biological: Ad5FGF-4
  2. Biological: Placebo
MeSH:Angina Pectoris Myocardial Ischemia Coronary Artery Disease Angina, Stable Ischemia
HPO:Angina pectoris Coronary artery atherosclerosis Myocardial infarction

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

Secondary Outcomes

Description: Canadian Cardiovascular Society (CCS) angina classification

Measure: Change in patient functional status (CCS class)

Time: Baseline and Month 6

Description: Average weekly angina episodes

Measure: Change in weekly angina frequency

Time: Baseline and Month 6

Description: Average weekly nitroglycerin usage

Measure: Change in weekly nitroglycerin usage

Time: Baseline and Month 6

Description: Seattle Angina Questionnaire

Measure: Change in quality of life

Time: Baseline and Month 6

Description: Adverse events and clinical laboratory testing

Measure: Safety of Ad5FGF-4

Time: Through Month 6

Description: Occurrence of clinically significant events

Measure: Long-term safety of Ad5FGF-4

Time: Through Month 60
2 Comparison of Quantitative Flow Ratio Guided and Angiography Guided Percutaneous InterVention in Patients With cORonary Artery Disease (The FAVOR III China Study)

The overall purpose of the FAVOR III China trial is to investigate if a strategy of quantitative flow ratio (QFR)-guided percutaneous coronary intervention (PCI) yields superior clinical outcome and cost-effectiveness compared to a strategy of standard coronary angiography-guided PCI in evaluation of patients with coronary artery disease.

NCT03656848
Conditions
  1. Coronary Artery Disease
  2. Myocardial Ischaemia
  3. Coronary Circulation
  4. Coronary Stenosis
  5. Percutaneous Coronary Intervention
Interventions
  1. Diagnostic Test: QFR
  2. Diagnostic Test: Angiography
MeSH:Coronary Artery Disease Myocardial Ischemia Coronary Disease Coronary Stenosis Ischemia
HPO:Coronary artery atherosclerosis Coronary artery stenosis Myocardial infarction

Primary Outcomes

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

Measure: MACE

Time: 1 year

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

Description: Cardiovascular, non-cardiovascular and undetermined death

Measure: Death

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

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

Measure: MI

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

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

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

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

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

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

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
3 LIFE-BTK (pivotaL Investigation of saFety and Efficacy of BRS Treatment-Below The Knee) Randomized Controlled Trial

Pre-market clinical evaluation of the everolimus eluting ESPRIT™ BTK System for the planned treatment of narrowed infrapopliteal lesions.

NCT04227899
Conditions
  1. Critical Limb Ischemia (CLI)
Interventions
  1. Device: ESPRIT™ BTK Device
  2. Device: Percutaneous Transluminal Angioplasty (PTA) Device
MeSH:Ischemia

Primary Outcomes

Description: It includes freedom from: above ankle amputation in index limb, 100% total occlusion of target vessel and clinically-driven target lesion revascularization (CD-TLR).

Measure: Composite of Limb Salvage and Primary Patency at 6 Months

Time: At 6 months

Description: MALE includes above ankle amputation in index limb, major re-intervention at 6 months and POD includes perioperative (30 day) mortality.

Measure: Freedom from MALE+POD (Major Adverse Limb Event + Peri-Operative Death)

Time: At 30 days (for POD) and 6 months (for MALE)

Secondary Outcomes

Description: Successful target lesion treatment is defined as final diameter stenosis < 30% with final number of run-off vessels equivalent to or greater than number of run-off vessels at pre-procedure, with no residual dissection NHLBI grade ≥ type C, and no transient or sustained angiographic complications (e.g. distal embolization, perforation, thrombosis). Achieved using balloons plus ESPRIT BTK in the treatment arm and balloons in the control arm. This is defined on a per lesion basis.

Measure: Number of Participants with Acute Procedure Success

Time: Immediately after the procedure

Description: Device success is defined on a per device basis, as the achievement of successful delivery and deployment of the study device(s) at the intended target lesion and successful withdrawal of the delivery catheter.

Measure: Number of Participants with Device Success

Time: During the procedure

Description: Technical success is defined on a per lesion basis as the attainment of a final residual stenosis of < 30% at the intended target lesion(s) following use of the study device(s). Standard pre-dilatation catheters and post-dilatation catheters (if applicable) may be used. Bailout at lesion level does not impact technical success if the above criteria are met.

Measure: Number of Participants with Technical Success

Time: During the procedure

Description: Clinical success is defined on a per patient basis, as the attainment of a final residual stenosis of < 30% using the study device(s) and/or any adjunctive device at all intended target lesion(s) without complications within 2 days after the index procedure or at hospital discharge, whichever is sooner.

Measure: Number of Participants with Clinical Success

Time: Within 2 days after the index procedure or at hospital discharge

Description: Acute gain is defined as the difference between post- and preprocedural minimal lumen diameter (MLD).

Measure: Number of Participants with Angiographic acute gain (in-segment)

Time: Immediately after the procedure

Description: Acute gain is defined as the difference between post- and preprocedural minimal lumen diameter (MLD). Angiographic acute gain (in-device) will be assessed for ESPRIT arm only

Measure: Number of Participants with Angiographic acute gain (in-device)

Time: Immediately after the procedure

Description: Composite of Limb Salvage and Primary Patency includes freedom from: above ankle amputation in index limb, 100% total occlusion of target vessel and clinically-driven target lesion revascularization (CD-TLR).

Measure: Composite of Limb Salvage and Primary Patency

Time: At 1 month, 3 months, 6 months, 1 year and annually through 5 years

Description: MALE includes above ankle amputation in index limb, major re-interventions at 1 month, 3 months, 6 months, 1 year and annually through 5 years, and POD includes perioperative (30 day) mortality.

Measure: Freedom From MALE+POD (Major Adverse Limb Event + Peri-Operative Death)

Time: At 1 month, 3 months, 6 months, 1 year and annually through 5 years

Measure: Freedom From Major Amputation and Clinically-driven Target Lesion Revascularization (CD-TLR)

Time: At 1 month, 3 months, 6 months, 1 year and annually through 5 years

Measure: Freedom From Above Ankle Amputation

Time: At 1 month, 3 months, 6 months, 1 year and annually through 5 years

Description: Freedom from re-narrowing of the artery following the alleviation of a previous narrowing. It is defined as the presence of a hemodynamically significant restenosis (≥ 50%), as determined by angiography.

Measure: Freedom From Restenosis

Time: At 1 month, 3 months, 6 months, 1 year and annually through 5 years

Measure: Number of Amputation-free Survival

Time: At 1 month, 3 months, 6 months, 1 year and annually through 5 years

Description: All-cause Death composed of cardiac death, vascular death and non-cardiovascular death

Measure: Number of All-cause Death

Time: At 1 month, 3 months, 6 months, 1 year and annually through 5 years

Description: Arterial thrombosis is defined as a total occlusion documented by duplex ultrasound and/or angiography at the site of the treated lesion with or without symptoms. Acute thrombosis: 0 - 24 hours post study procedure Subacute thrombosis: > 24 hours - 30 days post study procedure Late thrombosis: 31 days - 1 year post-procedure Very late thrombosis: > 1 year post-procedure Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the arterial sheath has been removed and the subject has left the interventional lab.

Measure: Number of Participants with Arterial Thrombosis

Time: At 1 month, 3 months, 6 months, 1 year and annually through 5 years

Description: Major Limb Re-interventions includes the creation of a new bypass graft, bypass graft revision, the use of thrombectomy or thrombolysis, or revascularization

Measure: Number of Participants with Major Re-intervention on index limb

Time: At 1 month, 3 months, 6 months, 1 year and annually through 5 years

Description: Primary assisted patency is defined as patency of the target lesion following endovascular reintervention at the target vessel site in case of symptomatic restenosis

Measure: Primary Assisted Patency

Time: At 1 month, 3 months, 6 months, 1 year and annually through 5 years

Description: Secondary patency is defined as patency of the target lesion after treatment of a (re)occlusion of the index lesion

Measure: Secondary Patency

Time: At 1 month, 3 months, 6 months, 1 year and annually through 5 years

Description: CD-TLR is the repeat intervention on the target lesion due to recurrent symptoms AND stenosis > 70% by angiography

Measure: Number of Participants with Clinically-driven Target Lesion Revascularization (CD-TLR)

Time: At 1 month, 3 months, 6 months, 1 year and annually through 5 years

Measure: Number of Participants with Clinically-driven Target Vessel Revascularization (CD-TVR)

Time: At 1 month, 3 months, 6 months, 1 year and annually through 5 years

Measure: Number of Participants with Clinically-driven Target Vessel Revascularization Distal to the Target Lesion

Time: At 1 month, 3 months, 6 months, 1 year and annually through 5 years

Measure: Number of Participants with Clinically-driven Target Vessel Revascularization Proximal to the Target Lesion

Time: At 1 month, 3 months, 6 months, 1 year and annually through 5 years

Description: Wound assessment will be performed to determine whether the wound is improving (i.e. healing), not changing, or worsening.

Measure: Target Wound Assessment for Healing

Time: At 14 days, 30 days, 42 days and 90 days

Description: Wound Assessment for Infection will be performed to determine the clinical indication of the presence or absence of infection.

Measure: Target Wound Assessment for Infection

Time: At 14 days, 30 days, 42 days and 90 days

Description: The Rutherford Becker scale is a classification system for claudication and limb ischemia. Categories and Clinical Description: Category 0 = Asymptomatic, no hemodynamically significant occlusive disease Grade I (Category 1 = Mild claudication, Category 2 = Moderate claudication, Category 3 = Severe claudication) Grade II (Category 4 = Ischemic rest pain) Grade III (Category 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, Category 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable).

Measure: Measurement of subject's Rutherford Becker Clinical Category, and change from baseline for the treated limb

Time: At baseline,1 month, 3 months, 6 months, 1 year and annually through 5 years
4 Endovascular Thrombectomy in COVID-19 Infected Patients: Intrahospital and Peri-operative Outcomes

About 5% of COVID-19 patients may present symptoms related to acute ischemic stroke (AIS). Treatment-management and outcomes related to mechanical thrombectomy (MT) for COVID-19 infected patients harboring large vessel occlusion is largely unknown. This multicentric study aims to investigate morbidity, mortality and neurological outcomes after MT performed in patients with COVID-19 infection.

NCT04406090
Conditions
  1. Ischemic Stroke
  2. Covid 19
Interventions
  1. Other: Mechanical Trombectomy
MeSH:Stroke Ischemia
HPO:Stroke

Primary Outcomes

Description: Intrahospital mortality after MT for COVID-19 infected patients harboring large vessel occlusion

Measure: Intrahospital mortality

Time: 1day

Description: short-term morbidity after MT for COVID-19 infected patients harboring large vessel occlusion

Measure: short-term morbidity

Time: 1 day

Secondary Outcomes

Description: Angiographic success after MT for COVID-19 infected patients harboring large vessel occlusion

Measure: Angiographic success

Time: 1 day
5 Temsirolimus Adventitial Delivery to Improve ANGioplasty and/or Atherectomy Revascularization Outcomes Below the Knee: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Effect of Temsirolimus Perivascular Injection 0.1 mg/mL on the Incidence of Ischemia-Driven Major Amputation, Clinically Driven Target Lesion Revascularization, and Clinically Relevant Target Lesion Occlusion After Revascularization of Lesions Below the Knee in Patients With Symptomatic Rutherford 3-5 Peripheral Artery Disease

A multicenter, randomized, double-blind, placebo-controlled trial to evaluate the effect of Temsirolimus Perivascular Injection 0.1 mg/mL on the incidence of ischemia-driven major amputation, clinically driven target lesion revascularization, and clinically relevant target lesion occlusion after revascularization of lesions below the knee in patients with symptomatic Rutherford 3-5 peripheral artery disease. The primary safety endpoint will be gathered at 1-month post-index procedure. The primary efficacy endpoint will be gathered at 6 months post-index procedure. Participants will be followed for up to 5 years post-index procedure.

NCT04433572
Conditions
  1. Peripheral Artery Disease
  2. Critical Limb Ischemia
Interventions
  1. Drug: Temsirolimus
  2. Drug: Saline placebo
MeSH:Peripheral Arterial Disease Ischemia
HPO:Peripheral arterial stenosis

Primary Outcomes

Description: Superiority of treatment vs. control group in the composite freedom from the following: Clinically Relevant Target Lesion Occlusion Clinically Driven Target Lesion Revascularization Ischemia-Driven Major Amputation of the Target Limb

Measure: Freedom from Cinical Relevant Target Lesion Failure

Time: 6 Months

Description: Noninferiority of treatment vs. control groups in the composite freedom from Major Adverse Limb Event (MALE) in the target limb or Perioperative Death (POD)

Measure: MALE + POD

Time: 30 Days

Secondary Outcomes

Description: Superiority of treatment vs. control group in the composite freedom from the following: Target Lesion Occlusion Clinically Driven Target Lesion Revascularization Ischemia-Driven Major Amputation of the target limb

Measure: Freedom from Target Lesion Failure

Time: 6 Months

Description: Death at the following time points

Measure: To determine non-inferiority in long-term mortality rate

Time: 12, 24, 36, 48, 60 months

Description: Composite of all-cause death or MALE of the target limb

Measure: To determine non-inferiority in freedom from all-cause death or major adverse limb event.

Time: 30 days, 6, 12 months

Description: Freedom from death and ischemia-driven major amputation of the target limb

Measure: To determine non-inferiority in amputation-free survival.

Time: 30 days, 6, 12, 24 months

Description: AEs/ARs will be categorized into one of the following: MALE of the target limb Non-MALE target limb SAE/SAR Other SAE/SAR Non-serious AE/AR AEs/ARs will further be classified as: Expected UADE SUSAR AEs/ARs will also be classified for relatedness (definitely, probably, possibly or not) to the following: Revascularization procedure Use of the Bullfrog device The study drug

Measure: Safety and tolerability will be assessed from overall rate of adverse events (subclassified as major, serious, non-serious, unanticipated, revascularization procedure-related, device-related and drug-related).

Time: 30 days, 6, 12, 24 months

Description: Taken individually: Ischemia-driven major amputation of the target limb CD-TLR Clinically relevant target lesion occlusion Any target lesion occlusion

Measure: Change of the individual components of the primary and secondary endpoints (ischemia-driven major amputation, clinically driven target lesion revascularization, clinically relevant target lesion occlusion or all target lesion occlusion)

Time: 6, 12, 24 months

Description: MALE of the target limb

Measure: Freedom from major adverse limb events

Time: 30 days, 6, 12, 24 months

Description: Total size of foot wounds on the target limb, percent and absolute change from baseline Status of foot wounds on the target limb Unassisted wound healing

Measure: Composite of the following wound healing measures

Time: 30 days, 6, 12 months

Description: Unplanned minor amputation rate, overall and by level (forefoot, midfoot, hindfoot)

Measure: Reduction in unplanned minor amputations

Time: 30 days, 6, 12 months

Description: Rutherford category and change from baseline

Measure: Rutherford score improvement

Time: 30 days, 6, 12, 24 months

Description: WIfI category and change from baseline

Measure: WIfI score improvement

Time: 30 days, 6, 12, 24 months

Description: Ankle-brachial index and change from baseline Toe-brachial index and change from baseline Toe pressure and change from baseline

Measure: Composite of hemodynamic improvement measures (ABI, TBI and toe pressure)

Time: 30 days, 6, 12, 24 months

Description: VascuQoL results and change from baseline

Measure: Patient reported quality of life benefits (VascuQoL)

Time: 30 days, 6, 12, 24 months

Description: WIQ results and change from baseline

Measure: Patient reported outcomes (walking impairment questionnaire) benefits

Time: 30 days, 6, 12, 24 months

Description: Primary patency rate Primary assisted patency rate

Measure: Primary and primary assisted patency rates

Time: 30 days, 6, 12, 24 months

Description: Primary sustained clinical improvement rate Secondary sustained clinical improvement rate

Measure: Primary and secondary sustained clinical improvement rates

Time: 30 days, 6, 12, 24 months
6 The Impact of COVID-19 Pandemic on Critical Limb Threatening Ischemia and Emergency Vascular Practice

This is a retrospective analytical study conducted at Vascular and Endovascular surgery Department, Mansoura University Hospital, including all patients admitted at the two periods first six months of 2019 and 2020.To demonstrate the effect of COVID-19 pandemic on the practice of emergency vascular surgery and critical limb threatening ischemia interventions by comparison two periods first six months of 2019 and 2020.

NCT04452682
Conditions
  1. COVID
  2. Critical Limb Ischemia
Interventions
  1. Other: COVID 19 impact
MeSH:Emergencies Ischemia

Primary Outcomes

Description: The ICU admission caused by Pneumonia proved radio-logically at both periods

Measure: The ICU admission with associated Pneumonia

Time: 6 months

Description: percentage of different diagnoses at both periods

Measure: Impact of COVID-19 on the different presentation of vascular surgery at the emergency

Time: 6 months

Secondary Outcomes

Description: Mortality percentages at both periods

Measure: Mortality rates

Time: 6 months

HPO Nodes


HPO

Alphabetical listing of all HPO terms. Navigate: Correlations   Clinical Trials


HPO Nodes


Reports

Data processed on September 26, 2020.

An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.

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