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

Last updated: August 6, 2024
Sponsor: Pauls Stradins Clinical University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Coronary Artery Disease

Hypercholesterolemia

Carotid Artery Disease

Treatment

Coronary CT angiography and FFRct analysis

Clinical Study ID

NCT06546761
Latvia RCT/CAD/25062024
  • Ages > 50
  • All Genders

Study 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

Inclusion Criteria:

  1. Inform consent obtained before any study-related activities;

  2. Age above or equal to 50 years with symptomatic or asymptomatic critical carotidstenosis (symptomatic patients with at least Rankin III) which has been successfullyrevascularized by carotid endarterectomy or stenting within the past 14 days;

  3. Willing and able to undergo coronary CTA scan within 14 days of randomization andagrees to submission of CTA data set for HeartFlow FFRct analysis with results madeavailable to treating physician.

Exclusion

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 QTsyndrome;

  4. History of severe asthma, severe or bronchodilator-dependent Chronic obstructivepulmonary 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 bloodpressure <90 mmHg, or acute pulmonary edema;

  11. Any active, serious, life-threatening disease with a life expectancy of less than 2years;

  12. Any active infection;

  13. Inability to comply with study procedures;

  14. Contraindication for guideline-guided long-term antiplatelet/anticoagulation regimeafter PCI/CABG;

  15. Large neurologic deficit (Rankin scale >III);

  16. Participation in any interventional clinical study within 30 days prior toscreening.

Study Design

Total Participants: 300
Treatment Group(s): 1
Primary Treatment: Coronary CT angiography and FFRct analysis
Phase:
Study Start date:
June 25, 2024
Estimated Completion Date:
June 25, 2029

Study 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 infarction, no coronary angiography or coronary computed tomography angiography (CTA), and no coronary revascularization (PCI or CABG) who have undergone successful carotid artery revascularization with planned post-operative best medical therapy. Within 14 days following carotid revascularization, patients will be randomly assigned to BMT alone or BMT plus coronary CT angiography (which must be completed within 14 days of randomization) and FFRct analysis to determine the functional significance of coronary lesions identified on the CT scan. Results of the CT scan and FFRCT analysis in patients randomized to the CT-FFRct group, will be provided to treating physicians to help guide patient management with Vascular Heart Team consideration for coronary angiography and revascularization as appropriate for each patient. Coronary revascularization (PCI or CABG), if indicated, is strongly recommended within 3 months from the randomization. Clinical follow up (based on date of randomization) is planned 6 months, one and 2 years. Additional long-term follow up out to 5-years is planned for participating centers. An independent academic clinical events committee will adjudicate all endpoints in a blinded manner. The definition of outcome events will be in accordance with Academic Research Consortium-2 consensus document.

Connect with a study center

  • Pauls Stradins Clinical University Hospital

    Riga,
    Latvia

    Active - Recruiting

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