Actively Recruiting
Selective Coronary Revascularization in Carotid Artery Disease Patients After Carotid Revascularization (SCORECAD Trial)
Led by Pauls Stradins Clinical University Hospital · Updated on 2024-08-09
300
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating whether adding selective coronary revascularization based on coronary CT angiography (CTA) and fractional flow reserve derived from CT (FFRct) to best medical therapy (BMT) can reduce heart-related problems and improve survival in patients with carotid artery stenosis (CAS) who have no known coronary artery disease (CAD). This study focuses on patients who have had successful carotid artery revascularization and compares outcomes between those treated with BMT alone and those receiving BMT plus selective coronary revascularization guided by FFRct assessment. Participants are randomly assigned within 14 days after carotid revascularization to either BMT alone or BMT plus coronary CTA and FFRct analysis. Those in the CTA-FFRct group undergo a coronary CT scan to assess the significance of coronary artery lesions. Results from this analysis help doctors decide if coronary revascularization (percutaneous coronary intervention or bypass surgery) is needed and is recommended within 3 months of randomization. The study includes clinical follow-up visits at 6 months, 1 year, and 2 years, with additional long-term follow-up planned up to 5 years. During the study, participants will have assessments including coronary CT scans, FFRct analysis, and clinical evaluations to monitor heart-related events and survival. An independent committee reviews all outcome events without knowing patient group assignments. The main outcome measured is major adverse cardiac events over 2 years. Participants receive post-operative best medical therapy, and their health is closely monitored throughout the follow-up period to evaluate the impact of adding coronary imaging and possible revascularization.
CONDITIONS
Brief Title
Selective Coronary Revascularization in Carotid Artery Disease Patients After Carotid Revascularization (SCORECAD 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 or asymptomatic critical carotid stenosis successfully treated by carotid endarterectomy or stenting within the past 14 days
- Willing and able to undergo coronary CT angiography and FFRct analysis within 14 days of randomization and agree to submission of data for analysis with results shared with treating physician
You will not qualify if you...
- Known coronary artery disease, history of myocardial infarction, or prior coronary revascularization (PCI or CABG)
- Previous coronary angiography or coronary CT angiography before randomization
- History of 2nd or 3rd degree heart block, sick sinus syndrome, or long QT syndrome
- Severe asthma or bronchodilator-dependent chronic obstructive pulmonary disease
- Severe congestive heart failure (NYHA Class III or IV)
- Severe arrhythmia or prior pacemaker/internal defibrillator implantation
- Impaired kidney function (EPI-GFR less than 30 ml/min)
- Known allergy to iodinated contrast
- Pregnancy or unknown pregnancy status in participants of childbearing potential
- Ongoing clinical instability such as acute chest pain, cardiogenic shock, unstable blood pressure, or acute pulmonary edema
- Life expectancy less than 2 years due to serious disease
- Active infection
- Inability to comply with study procedures
- Contraindication for long-term antiplatelet/anticoagulation therapy after PCI/CABG
- Large neurologic deficit (Rankin scale greater than III)
- Participation in another interventional clinical study within 30 days prior to screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 14 days after carotid revascularization
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Within 14 days of randomization
Participants assigned to the diagnostic group undergo coronary CT angiography and FFRct analysis to assess coronary artery disease and guide further management.
1 visit (in-person)
Duration - Up to 5 years
Participants are monitored clinically with follow-up visits to assess cardiac events and overall health after carotid revascularization and medical therapy.
Follow-up visits at 6 months, 1 year, 2 years, and up to 5 years
Trial Site Locations
Total: 1 location
1
Pauls Stradins Clinical University Hospital
Riga, Latvia
Actively Recruiting
Research Team
D
Dainis Krievins, MD, PhD
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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