Covid 19 Research using Clinical Trials (Home Page)
Report for D007511: Ischemia NIH
(Synonyms: Isc, Isch, Ischem, Ischemia)
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (7)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug1448 | Mechanical Trombectomy Wiki | 0.50 |
| drug171 | Angiography Wiki | 0.50 |
| drug1960 | QFR Wiki | 0.50 |
| drug1266 | Isotretinoin Only Product in Oral Dose Form Wiki | 0.50 |
| drug2182 | Saline placebo Wiki | 0.50 |
| drug448 | COVID 19 impact Wiki | 0.50 |
| drug2471 | Temsirolimus Wiki | 0.50 |
Correlated MeSH Terms (7)
| Name (Synonyms) | Correlation | |
|---|---|---|
| D023921 | Coronary Stenosis NIH | 0.50 |
| D058729 | Peripheral Arterial Disease NIH | 0.29 |
| D003327 | Coronary Disease NIH | 0.25 |
| D003324 | Coronary Artery Disease NIH | 0.25 |
| D009203 | Myocardial Ischemia NIH | 0.18 |
| D020521 | Stroke NIH | 0.16 |
| D004630 | Emergencies NIH | 0.10 |
Correlated HPO Terms (5)
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0005145 | Coronary artery stenosis HPO | 0.50 |
| HP:0001677 | Coronary artery atherosclerosis HPO | 0.25 |
| HP:0004950 | Peripheral arterial stenosis HPO | 0.22 |
| HP:0001658 | Myocardial infarction HPO | 0.18 |
| HP:0001297 | Stroke HPO | 0.16 |
There are 4 clinical trials
Clinical Trials
1 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 Coronary Artery Disease Myocardial Ischaemia Coronary Circulation Coronary Stenosis Percutaneous Coronary Intervention Diagnostic Test: QFR 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
2 Endovascular Thrombectomy in COVID-19 Infected Patients: Intrahospital and Peri-operative Outcomes
Primary Outcomes
Description: A composite of all-cause mortality, any myocardial infarction and any ischemia-driven revascularization
Measure: MACE Time: 1 yearSecondary 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 yearDescription: Cardiovascular, non-cardiovascular and undetermined death
Measure: Death Time: 1 month, 6 months, 1 year, 2 years and 3 yearsDescription: Target vessel related and non-target vessel related MI
Measure: MI Time: 1 month, 6 months, 1 year, 2 years and 3 yearsDescription: The ischemia driven and non-ischemia driven TVR
Measure: Target vessel revascularization (TVR) Time: 1 month, 6 months, 1 year, 2 years and 3 yearsDescription: 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 yearsDescription: 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 yearsDescription: 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 procedureDescription: 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 yearDescription: 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 yearAbout 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 Ischemic Stroke Covid 19 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
3 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
Primary Outcomes
Description: Intrahospital mortality after MT for COVID-19 infected patients harboring large vessel occlusion
Measure: Intrahospital mortality Time: 1dayDescription: short-term morbidity after MT for COVID-19 infected patients harboring large vessel occlusion
Measure: short-term morbidity Time: 1 daySecondary Outcomes
Description: Angiographic success after MT for COVID-19 infected patients harboring large vessel occlusion
Measure: Angiographic success Time: 1 dayA 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 Peripheral Artery Disease Critical Limb Ischemia Drug: Temsirolimus 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
4 The Impact of COVID-19 Pandemic on Critical Limb Threatening Ischemia and Emergency Vascular Practice
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 MonthsDescription: 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 DaysSecondary 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 MonthsDescription: Death at the following time points
Measure: To determine non-inferiority in long-term mortality rate Time: 12, 24, 36, 48, 60 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: MALE of the target limb
Measure: Freedom from major adverse limb events Time: 30 days, 6, 12, 24 monthsDescription: 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 monthsDescription: Unplanned minor amputation rate, overall and by level (forefoot, midfoot, hindfoot)
Measure: Reduction in unplanned minor amputations Time: 30 days, 6, 12 monthsDescription: Rutherford category and change from baseline
Measure: Rutherford score improvement Time: 30 days, 6, 12, 24 monthsDescription: WIfI category and change from baseline
Measure: WIfI score improvement Time: 30 days, 6, 12, 24 monthsDescription: 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 monthsDescription: VascuQoL results and change from baseline
Measure: Patient reported quality of life benefits (VascuQoL) Time: 30 days, 6, 12, 24 monthsDescription: WIQ results and change from baseline
Measure: Patient reported outcomes (walking impairment questionnaire) benefits Time: 30 days, 6, 12, 24 monthsDescription: Primary patency rate Primary assisted patency rate
Measure: Primary and primary assisted patency rates Time: 30 days, 6, 12, 24 monthsDescription: Primary sustained clinical improvement rate Secondary sustained clinical improvement rate
Measure: Primary and secondary sustained clinical improvement rates Time: 30 days, 6, 12, 24 monthsThis 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 COVID Critical Limb Ischemia 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 monthsDescription: percentage of different diagnoses at both periods
Measure: Impact of COVID-19 on the different presentation of vascular surgery at the emergency Time: 6 monthsSecondary Outcomes
Description: Mortality percentages at both periods
Measure: Mortality rates Time: 6 months