Early Detection of Cardiovascular Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

610 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-12-06

Study Completion Date

2022-01-11

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.

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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

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.

Conditions

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Atheroma Cardiac Disease Vascular Diseases Atherosclerosis Myocardial Infarction Acute Coronary Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cardiac outpatients

Subjects referred for outpatient coronary angiography.

Ultrasound

Intervention Type OTHER

Contrast-enhanced ultrasound (CEUS)

Interventions

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Ultrasound

Contrast-enhanced ultrasound (CEUS)

Intervention Type OTHER

Other Intervention Names

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Contrast injection - Definity(R)

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No