Phase
Condition
Coronary Artery Disease
Hypercholesterolemia
Carotid Artery Disease
Treatment
Coronary CT angiography and FFRct analysis
Clinical Study ID
Ages > 50 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Inform consent obtained before any study-related activities;
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;
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:
Known CAD, history of MI, prior coronary revascularization (PCI or CABG);
Patient underwent coronary angiography or coronary CTA before the randomization;
Known history of 2nd or 3rd degree heart block; sick sinus syndrome; long QTsyndrome;
History of severe asthma, severe or bronchodilator-dependent Chronic obstructivepulmonary disease (COPD);
Severe congestive heart failure (NYHA III or IV);
Severe arrhythmia, prior pacemaker or internal defibrillator lead implantation;
Impaired chronic renal function (EPI-GFR<30ml/min);
Subjects with known anaphylactic allergy to iodinated contrast;
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 bloodpressure <90 mmHg, or acute pulmonary edema;
Any active, serious, life-threatening disease with a life expectancy of less than 2years;
Any active infection;
Inability to comply with study procedures;
Contraindication for guideline-guided long-term antiplatelet/anticoagulation regimeafter PCI/CABG;
Large neurologic deficit (Rankin scale >III);
Participation in any interventional clinical study within 30 days prior toscreening.
Study Design
Study Description
Connect with a study center
Pauls Stradins Clinical University Hospital
Riga,
LatviaActive - Recruiting
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