Selective coronary revascularization for patients with carotid artery disease after carotid surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate whether a combination of best medical therapy and selective coronary revascularization, guided by FFRct assessment, can reduce adverse cardiac events in patients with carotid artery stenosis who have recently undergone carotid revascularization. Patients aged 50 and older, both symptomatic and asymptomatic, will be randomly assigned to receive either best medical therapy alone or best medical therapy plus coronary CT angiography and FFRct analysis. The study will follow participants for up to five years to assess the impact on cardiac outcomes. An independent committee will evaluate the clinical events to ensure unbiased results.

Why it matters

Who can join: the full rules

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.

Where it's running

• Pauls Stradins Clinical University Hospital
  Riga, Latvia Recruiting

Study contacts

• Study coordinator: Dainis Krievins, MD, PhD
• Email: dainis.krievins@gmail.com
• Phone: +371 29450000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.