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Correlation Between Coronary and Carotid Atherosclerotic Disease and Links With Clinical Outcomes (MHICC3ROW)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02114541
Recruitment Status : Completed
First Posted : April 15, 2014
Last Update Posted : February 28, 2020
Sponsor:
Information provided by (Responsible Party):
Jean-Claude Tardif, Montreal Heart Institute

Brief Summary:
The relationship of the natural history of atherosclerosis between different vascular beds has not been well characterized. Determination and comparison of the relative rates of progression and extents of atherosclerosis in the coronary and carotid arterial trees may have major impacts on clinical research and clinical practice. Correlation between findings in the carotid and coronary circulations is an important scientific and clinical topic to address. Results from a well design study incorporating imaging technologies that currently represent the gold standards for the assessment of coronary and carotid artery plaque burden, will have potentially impact on clinical research and clinical practice.

Condition or disease
Vascular Disease

Detailed Description:

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.

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Study Type : Observational
Actual Enrollment : 228 participants
Observational Model: Other
Time Perspective: Prospective
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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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).

  5. 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.


Other Outcome Measures:
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 87 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients who have successfully undergone baseline imaging in the dal-PLAQUE 2 study
Criteria

Inclusion Criteria:

  • written informed consent
  • patients who have successfully undergone baseline IVUS imaging, with or without baseline carotid ultrasound IMT assessment, in the dal-PLAQUE 2 study

Exclusion Criteria:

  • none applicable

Information from the National Library of Medicine

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


Locations
Show Show 29 study locations
Sponsors and Collaborators
Montreal Heart Institute
Investigators
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Principal Investigator: Jean-Claude Tardif, M.D Montreal Heart Institute
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Responsible Party: Jean-Claude Tardif, P.I., Montreal Heart Institute
ClinicalTrials.gov Identifier: NCT02114541    
Other Study ID Numbers: MHICC-31052012
First Posted: April 15, 2014    Key Record Dates
Last Update Posted: February 28, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Carotid Artery Diseases
Vascular Diseases
Cardiovascular Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases