Vascular Imaging as a Barometer for the Early Detection of Cardiovascular Disease
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Atheroma
- Sponsor
- Dr. Amer Johri
- Enrollment
- 610
- Locations
- 1
- Primary Endpoint
- Maximum Plaque Height (physiological parameter)
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
The investigators plan to evaluate the correlation between carotid plaque enhancement on Contrast-enhanced ultrasound (CEUS), significant coronary artery disease (CAD), and cardiovascular (CV) outcomes in a systematic manner. The investigators hypothesize that increased levels of CEUS-detected vulnerable carotid plaque will be predictive of CV risk determined by angiography and future cardiovascular events.
Detailed Description
Study Design: The investigators will conduct a prospective, single-center, observational study at the Cardiovascular Imaging Network at Queen's (CINQ, www.CINQLab.com). This facility allows a CEUS protocol to be conducted on the same day as the angiogram. It is anticipated that 100 participants can be recruited per month with a total target enrolment of up to 1000 participants. Objectives 1. To determine the test characteristics (sensitivity, specificity, negative/positive predictive values) of carotid plaque by CEUS (Definity(R)) for predicting significant CAD (≥50% stenosis) in participants referred for angiography 2. To determine the test characteristics (sensitivity, specificity, predictive values) of carotid plaque by CEUS for predicting future CV events, such as death, stroke, myocardial infarction, and cardiovascular interventions.
Investigators
Dr. Amer Johri
Associate Professor
Queen's University
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Maximum Plaque Height (physiological parameter)
Time Frame: 4 years
Caliper measurement of carotid plaque height on ultrasound images, using GE EchoPAC software. The maximum height of either side will be used to correlate to severity of angiographic CAD and neovascularization score.
Total Plaque Area (physiological parameter)
Time Frame: 4 years
Area measurement of carotid plaque on ultrasound images (right + left side), using GE EchoPAC software. The total plaque area will be used to correlate to severity of angiographic CAD and neovascularization score.
Neovascularization (contrast enhancement intensity) (physiological parameter)
Time Frame: 4 years
A neovascularization score will be used to grade the "activity" of the carotid plaque per participants and be correlated to angiographic CAD, visualized and manually counted using GE EchoPAC software.
Contrast wash-in time (physiological parameter)
Time Frame: 4 years
Time of contrast entering the plaque will be assessed to see if it correlates to severity of angiographic CAD, using GE EchoPAC software.
Secondary Outcomes
- Participants CV outcome follow-up (data linkage through the Institute for Clinical Evaluative Sciences: ICES)(5 years)