Actively Recruiting
Selective Coronary Revascularization in Peripheral Artery Disease Patients (SCOREPAD Trial)
Led by Pauls Stradins Clinical University Hospital · Updated on 2024-02-16
600
Participants Needed
1
Research Sites
261 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The primary objective of this study is to determine whether among symptomatic Peripheral Arterial Disease (PAD) patients with no known Coronary Artery Disease (CAD) who had undergone lower-extremity revascularization, a strategy of best medical therapy (BMT) plus selective coronary revascularization based on FFRct assessment of lesion-specific coronary ischemia can reduce adverse cardiac events and improve survival compared to BMT alone. Lesion-specific coronary ischemia is defined as FFRCT ≤0.80 distal to stenosis in a major (≥2 mm) coronary artery with severe ischemia defined as FFRCT ≤0.75.
CONDITIONS
Official Title
Selective Coronary Revascularization in Peripheral Artery Disease Patients (SCOREPAD Trial)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Informed consent obtained before any study-related activities
- Age 50 years or older with symptomatic lower extremity PAD (severe claudication or chronic limb-threatening ischemia, Rutherford 3,4,5)
- Successful lower extremity revascularization by open surgical or endovascular procedure within the past 14 days
- Willing and able to undergo coronary CTA scan within 14 days of randomization and agree to submission of CTA data for HeartFlow FFRct analysis with results available to treating physician
You will not qualify if you...
- Known Coronary Artery Disease, history of myocardial infarction, or prior coronary revascularization (PCI or CABG)
- Prior coronary angiography or coronary CTA before randomization
- History of 2nd or 3rd degree heart block, sick sinus syndrome, or long QT syndrome
- Severe asthma or severe/bronchodilator-dependent Chronic Obstructive Pulmonary Disease (COPD)
- Severe congestive heart failure (NYHA class III or IV)
- Severe arrhythmia or prior pacemaker/internal defibrillator implantation
- Impaired chronic renal function with GFR less than 30 ml/min
- Known anaphylactic allergy to iodinated contrast
- Pregnancy or unknown pregnancy status in subjects of childbearing potential
- Evidence of active clinical instability including acute chest pain, cardiogenic shock, unstable blood pressure (systolic <90 mmHg), or acute pulmonary edema
- Any active, serious, life-threatening disease with life expectancy under 2 years
- Any active infection
- Inability to comply with study procedures
- Contraindication for guideline-guided long-term antiplatelet/anticoagulation after PCI/CABG
- Participation in any interventional clinical study within 30 days prior to screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Pauls Stradins Clinical University hospital
Riga, Latvia
Actively Recruiting
Research Team
D
Dainis Krievins, MD, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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