Status:
RECRUITING
Selective Coronary Revascularization in Carotid Artery Disease Patients After Carotid Revascularization (SCORECAD Trial)
Lead Sponsor:
Pauls Stradins Clinical University Hospital
Conditions:
Carotid Stenosis
Coronary Artery Disease
Eligibility:
All Genders
50+ years
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 caro...
Detailed Description
This study targets a population of patients with symptomatic or asymptomatic carotid artery stenosis (CAS) (symptomatic to asymptomatic in 1:1 ratio) and no prior cardiac history, no myocardial infarc...
Eligibility Criteria
Inclusion
- Inform consent obtained before any study-related activities;
- 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;
- 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
- Known CAD, history of MI, prior coronary revascularization (PCI or CABG);
- Patient underwent coronary angiography or coronary CTA before the randomization;
- Known history of 2nd or 3rd degree heart block; sick sinus syndrome; long QT syndrome;
- History of severe asthma, severe or bronchodilator-dependent Chronic obstructive pulmonary disease (COPD);
- Severe congestive heart failure (NYHA III or IV);
- Severe arrhythmia, prior pacemaker or internal defibrillator lead implantation;
- Impaired chronic renal function (EPI-GFR\<30ml/min);
- Subjects with known anaphylactic allergy to iodinated contrast;
- Pregnancy or unknown pregnancy status in subject of childbearing potential;
- Evidence of ongoing or active clinical instability, including acute chest pain (sudden onset), cardiogenic shock, unstable blood pressure with systolic blood pressure \<90 mmHg, or acute pulmonary edema;
- Any active, serious, life-threatening disease with a life expectancy of less than 2 years;
- Any active infection;
- Inability to comply with study procedures;
- Contraindication for guideline-guided long-term antiplatelet/anticoagulation regime after PCI/CABG;
- Large neurologic deficit (Rankin scale \>III);
- Participation in any interventional clinical study within 30 days prior to screening.
Key Trial Info
Start Date :
June 25 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 25 2029
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06546761
Start Date
June 25 2024
End Date
June 25 2029
Last Update
August 9 2024
Active Locations (1)
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1
Pauls Stradins Clinical University Hospital
Riga, Latvia