Selective Coronary Revascularization in Carotid Artery Disease Patients After Carotid Revascularization (SCORECAD Trial)

Launched by PAULS STRADINS CLINICAL UNIVERSITY HOSPITAL · Aug 6, 2024

Keywords

ClinConnect Summary

The SCORECAD Trial is a study designed to find out if a combined approach of best medical therapy and selective heart procedures can help patients with narrowing of the carotid arteries (carotid stenosis) who have recently had surgery to open these arteries. Specifically, the trial is looking at patients who do not have known coronary artery disease but may have issues with blood flow to the heart. By using a special test to assess blood flow, researchers want to see if treating only the specific areas of the heart that need attention can lower the risk of serious heart problems and improve survival compared to just providing standard medical treatment.

To join the trial, participants need to be at least 50 years old and have had surgery for carotid artery narrowing within the last two weeks. They should also be willing to undergo a heart scan shortly after joining the study. However, those with a history of heart disease, certain serious health conditions, or specific complications may not be eligible. Participants can expect to receive careful monitoring and follow-up care during the study, which aims to better understand how to improve heart health in patients with carotid artery issues.

Gender

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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 pacemaker or internal defibrillator lead implantation;
• • 7. Impaired chronic renal function (EPI-GFR\<30ml/min);
• • 8. Subjects with known anaphylactic allergy to iodinated contrast;
• • 9. Pregnancy or unknown pregnancy status in subject of childbearing potential;
• • 10. 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;
• • 11. Any active, serious, life-threatening disease with a life expectancy of less than 2 years;
• • 12. Any active infection;
• • 13. Inability to comply with study procedures;
• • 14. Contraindication for guideline-guided long-term antiplatelet/anticoagulation regime after PCI/CABG;
• • 15. Large neurologic deficit (Rankin scale \>III);
• • 16. Participation in any interventional clinical study within 30 days prior to screening.