Early Detection of Cardiovascular Disease

Study Overview
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Brief Summary
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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
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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 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 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.

Official Title
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Vascular Imaging as a Barometer for the Early Detection of Cardiovascular Disease

Conditions
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Atheroma, Cardiac Disease, Vascular Diseases, Atherosclerosis, Myocardial Infarction, Acute Coronary Syndrome

Intervention / Treatment
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* Other: Ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: >18 years of age Outpatients referred for clinically indicated angiography for assessment of CAD Low - Intermediate Framingham risk (<20%) Absence of clinical contraindication to angiography Able and willing to give informed consent Exclusion criteria: Patients presenting with acute coronary syndrome Patients with previously known significant CAD (any lesion >50%) or percutaneous coronary intervention or coronary artery bypass surgery Previous carotid surgery or angioplasty Documented allergy to echo contrast

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cardiac outpatients<br>Subjects referred for outpatient coronary angiography. | Other: Ultrasound<br>* Contrast-enhanced ultrasound (CEUS)<br>* Other names: Contrast injection - Definity(R);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Plaque Height (physiological parameter) | 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. | 4 years | 
| Total Plaque Area (physiological parameter) | 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. | 4 years | 
| Neovascularization (contrast enhancement intensity) (physiological parameter) | 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. | 4 years | 
| Contrast wash-in time (physiological parameter) | Time of contrast entering the plaque will be assessed to see if it correlates to severity of angiographic CAD, using GE EchoPAC software. | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants CV outcome follow-up (data linkage through the Institute for Clinical Evaluative Sciences: ICES) | Participants will be followed for major adverse cardiac event over 5 years. Number of events will be correlated to carotid plaque measurements. | 5 years |