NCT06546761 Selective Coronary Revascularization in Carotid Artery Disease Patients After Carotid Revascularization (SCORECAD Trial)
| NCT ID | NCT06546761 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Pauls Stradins Clinical University Hospital |
| Condition | Carotid Stenosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2024-06-25 |
| Primary Completion | 2027-06-25 |
Trial Parameters
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Brief Summary
The primary objective of this study is to determine whether among symptomatic and asymptomatic carotid artery stenosis (CAS) patients with no known coronary artery disease (CAD) who had undergone carotid artery revascularization (endarterectomy of stenting) 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.
Eligibility Criteria
Inclusion Criteria: 1. Inform consent obtained before any study-related activities; 2. Age above or equal to 50 years with symptomatic or asymptomatic critical carotid stenosis (symptomatic patients with at least Rankin III) which has been successfully revascularized by carotid endarterectomy or stenting within the past 14 days; 3. Willing and able to undergo coronary CTA scan within 14 days of randomization and agrees to submission of CTA data set for HeartFlow FFRct analysis with results made available to treating physician. Exclusion Criteria: 1. Known CAD, history of MI, prior coronary revascularization (PCI or CABG); 2. Patient underwent coronary angiography or coronary CTA before the randomization; 3. Known history of 2nd or 3rd degree heart block; sick sinus syndrome; long QT syndrome; 4. History of severe asthma, severe or bronchodilator-dependent Chronic obstructive pulmonary disease (COPD); 5. Severe congestive heart failure (NYHA III or IV); 6. Severe arrhythmia, prior pacem