Early Detection of Cardiovascular Disease

Completed

• Conditions: Acute Coronary Syndrome; Cardiac Disease; Myocardial Infarction; Vascular Diseases; Atherosclerosis; Atheroma
• Interventions: Other: Ultrasound

• Registration Number: NCT03466255
• Lead Sponsor: Dr. Amer Johri

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.

Study Timeline

• Study Start: 2016-12-06
• Study First Submitted: 2018-02-27
• Study First Submitted QC: 2018-03-08
• Study First Posted: 2018-03-15
• Primary Completion: 2021-06-08
• Study Completion: 2022-01-11
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-08
• Last Update Posted: 2022-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 610

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cardiac outpatients	Ultrasound	Subjects referred for outpatient coronary angiography.

Primary Outcome Measures

Name	Time	Method
Maximum Plaque Height (physiological parameter)	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)	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)	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)	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 Outcome Measures

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

Trial Locations

Locations (1)

Queen's University, Cardiovascular Imaging Network at Queen's (CINQ), Kingston General Hospital; 🇨🇦 Kingston, Ontario, Canada