Correlation Between Coronary and Carotid Atherosclerotic Disease and Links With Clinical Outcomes (MHICC3ROW)
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|ClinicalTrials.gov Identifier: NCT02114541|
Recruitment Status : Completed
First Posted : April 15, 2014
Last Update Posted : February 28, 2020
|Condition or disease|
This is a prospective, observational, multi-center study expecting to enroll approximately 500 patients who have successfully undergone baseline imaging in the dal-PLAQUE 2 study.
- Patients who have had baseline angiography and IVUS, with or without baseline carotid ultrasound IMT assessments but NOT undergone follow-up angiography and IVUS as part of the dal-PLAQUE 2 study to have a follow-up angiogram and IVUS performed within 18-27 months of their baseline imaging.
- Patients who have had baseline carotid ultrasound IMT assessments but NOT undergone a follow-up carotid ultrasound IMT assessment within 18-27 months following enrollment into dal-PLAQUE 2 to have a follow up carotid ultrasound examination performed within 18-27 months of their baseline imaging.
- Patients to be contacted by phone on a annual bases at 3, 4, and 5 years following randomization into dal-PLAQUE 2 to collect cardiovascular and cerebrovascular clinical endpoints.
|Study Type :||Observational|
|Actual Enrollment :||228 participants|
|Official Title:||Global Observational Study to Evaluate the Correlation Between Coronary and Carotid Atherosclerotic Disease (CAD) and Links With Clinical Outcomes|
|Study Start Date :||May 2012|
|Actual Primary Completion Date :||December 12, 2014|
|Actual Study Completion Date :||December 12, 2016|
- Nominal change at follow-up from baseline in percent atheroma volume (PAV) obtained using intravascular ultrasound (IVUS) [ Time Frame: Participants will have a baseline IVUS and a two year follow-up IVUS ]This endpoint will be the nominal change at follow-up from baseline in percent atheroma volume computed by dividing plaque volume by external elastic membrane volume and then multiplying by 100 at both time points, baseline and 2 year follow-up.
- plaque volume in target coronary artery [ Time Frame: change at 2 year follow-up from baseline ]This secondary IVUS endpoint will include the nominal change in plaque volume in the target coronary artery, as well as the percent (relative) change in plaque volume.
- change in plaque volume in the 5-mm sub-segment of target coronary artery [ Time Frame: change at 2 year follow-up from baseline ]change in plaque volume in the 5-mm sub-segment with the greatest disease burden at baseline, and change in plaque volume in the 5-mm sub-segment with the smallest plaque area at baseline.
- Total vessel volume in the target coronary artery [ Time Frame: change at final 2 year follow-up from baseline ]Total vessel volume for all anatomically comparable slices in the 30-mm target coronary artery segment and the change in plaque characterization indices.
- change in coronary score assessed by quantitative coronary angiography [ Time Frame: change at final 2 year follow-up from baseline ]Evaluation of change in coronary score assessed by quantitative coronary angiography and defined as the per-patient mean of the minimal lumen diameter for all lesions measured. As well evaluation of the cumulative coronary stenosis score (calculated by adding all percent diameter stenoses in standard international units).
- nominal change in carotid IMT(CIMT) [ Time Frame: change at final 2 year follow-up from baseline ]This secondary endpoint will be obtained using 2D B-mode carotid ultrasound and will be the nominal change at final follow-up from baseline in carotid IMT(CIMT), where CIMT is computed as the per scan average of the mean IMT values of carotid segments.
- clinical endpoints [ Time Frame: up to five year follow-up ]Clinical endpoints: death, coronary heart disease, resuscitated cardiac arrest, non-fatal myocardial infarction, stroke, hospitalization for documented acute coronary syndrome (ECG abnormalities without biomarkers), coronary revascularization procedure and carotid artery surgery or angioplasty.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02114541
|Principal Investigator:||Jean-Claude Tardif, M.D||Montreal Heart Institute|