Correlation Between Coronary and Carotid Atherosclerotic Disease (CAD) and Links With Clinical Outcomes
This is a prospective, multi-center imaging study expecting to enroll approximately 1350 patients scheduled for clinically-indicated coronary angiography. Following informed consent, patient will undergo baseline coronary intravascular ultrasound (IVUS) imaging and non-invasive ultrasound imaging of their carotid arteries. Following a 2-year follow-up period, patients will undergo repeat coronary IVUS and standard invasive coronary angiography as well as carotid ultrasound examination.
Additionally, patients will be contacted by phone on an annual basis for 5 years to collect cardiovascular and cerebrovascular clinical endpoints. Evaluations of plaque burden will be made using invasive and non invasive imaging tools in order to assess correlations between vascular beds, imaging technologies and main cardiovascular events.
|Study Design:||Time Perspective: Prospective|
|Official Title:||Correlation Between Coronary and Carotid Atherosclerotic Disease (CAD) and Links With Clinical Outcomes|
- co-primary outcome measure - Nominal change from baseline in percent atheroma volume [ Time Frame: 2 years ] [ Designated as safety issue: No ]intravascular ultrasound measure
- co-primary outcome measure - nominal change from baseline in carotid IMT [ Time Frame: 2 years ] [ Designated as safety issue: No ]2D B-mode carotid ultrasound measure
- cardiovascular morbidity and mortality [ Time Frame: 5 years ] [ Designated as safety issue: No ]as adjudicated by a Clinical Endpoint Committee
Biospecimen Retention: Samples With DNA
samples stored for potential correlation with imaging and cardiovascular outcomes endpoints in subset of patients (optional)
|Study Start Date:||January 2010|
|Estimated Study Completion Date:||March 2018|
|Estimated Primary Completion Date:||September 2017 (Final data collection date for primary outcome measure)|
CTA and PET Substudy:
A subset of patients enrolled into the main CAIN3 study will undergo a CTA. At sites where both CTA and PET imaging modalities exist, patients will be asked to undergo both tests. The CTA and PET scans can be done separately on 2 imaging beds on different days or performed on the same imaging bed, resulting in a combined CTA and PET scan being done in one scheduled visit. All imaging will be done within 90 days after the follow up IVUS.
The choice of radiotracer used (NaF or FDG) for PET imaging will be dependent upon site and availability on the day of the scan. A total of 120 patients will be enrolled in this substudy with approximately 50-60 undergoing CTA and PET.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01353612
Show 39 Study Locations
|Study Chair:||Jean-Claude Tardif, MD||Montreal Heart Institute|