Early Detection of Cardiovascular Disease

Myocardial Infarction Clinical Trial

— VIBE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03466255
• Other study ID #: DMED-1927-16
• Secondary ID: CG#17006ER15-11-
• Status: Completed
• Start date: December 6, 2016
• Est. completion date: January 11, 2022

Study information

• Verified date: June 2022
• Source: Queen's University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 610
• Est. completion date: January 11, 2022
• Est. primary completion date: June 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Atheroma
• Atherosclerosis
• Cardiac Disease
• Cardiovascular Diseases
• Heart Diseases
• Infarction
• Myocardial Infarction
• Plaque, Atherosclerotic
• Vascular Diseases

Intervention

Other:
• Ultrasound
Contrast-enhanced ultrasound (CEUS)

Locations

Country	Name	City	State
Canada	Queen's University, Cardiovascular Imaging Network at Queen's (CINQ), Kingston General Hospital	Kingston	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Dr. Amer Johri	Lantheus Medical Imaging

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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

External Links

•   Cardiovascular Imaging Network at Queen's