Early Detection of Cardiovascular Disease

Dr. Amer Johri610 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

610

Conditions

Atheroma Cardiac Disease Vascular Diseases Atherosclerosis Myocardial Infarction Acute Coronary Syndrome

Interventions

UltrasoundOTHER

Contrast-enhanced ultrasound (CEUS)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion criteria: 1. \>18 years of age 2. Outpatients referred for clinically indicated angiography for assessment of CAD 3. Low - Intermediate Framingham risk (\<20%) 4. Absence of clinical contraindication to angiography 5. Able and willing to give informed consent Exclusion criteria: 1. Patients presenting with acute coronary syndrome 2. Patients with previously known significant CAD (any lesion \>50%) or percutaneous coronary intervention or coronary artery bypass surgery 3. Previous carotid surgery or angioplasty 4. Documented allergy to echo contrast

Locations (1)

Queen's University, Cardiovascular Imaging Network at Queen's (CINQ), Kingston General Hospital

Kingston, Ontario, Canada

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 4 years

Secondary Outcomes

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.

Time frame: 5 years

Data from ClinicalTrials.gov

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