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NCT06546761Recruiting

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

Source: ClinicalTrials.gov · Last updated 9 Aug 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
300 (estimated)
First submitted
6 Aug 2024
Start date
25 Jun 2024
Primary completion date
25 Jun 2027
Lead sponsor
Pauls Stradins Clinical University Hospital
NCT number
NCT06546761

What you commit to

  • Study type: Observational
  • Planned participants: 300
  • From 25 Jun 2024 to the primary completion date, 25 Jun 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Known CAD, history of MI, prior coronary revascularization (PCI or CABG);
  • Severe arrhythmia, prior pacemaker or internal defibrillator lead implantation;
  • Participation in any interventional clinical study within 30 days prior to screening.

Other illness

  • History of severe asthma, severe or bronchodilator-dependent Chronic obstructive pulmonary disease (COPD);
  • Severe congestive heart failure (NYHA III or IV);
  • Subjects with known anaphylactic allergy to iodinated contrast;
  • Any active, serious, life-threatening disease with a life expectancy of less than 2 years;
  • Any active infection;

Lab values

  • Known history of 2nd or 3rd degree heart block; sick sinus syndrome; long QT syndrome;
  • Impaired chronic renal function (EPI-GFR\<30ml/min);

Other

  • Patient underwent coronary angiography or coronary CTA before the randomization;
  • 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;
  • Inability to comply with study procedures;
  • Contraindication for guideline-guided long-term antiplatelet/anticoagulation regime after PCI/CABG;
  • Large neurologic deficit (Rankin scale \>III);

Who the study is looking for

  • 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.

Age in the registry: 50 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Pauls Stradins Clinical University Hospital
Coordinator of this site? Confirm its status
RigaLatviaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.