Early Detection of Cardiovascular Disease (VIBE)

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

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 Overview

• Status: Completed
• Conditions: Myocardial Infarction; Vascular Diseases; Atherosclerosis; Acute Coronary Syndrome; Cardiac Disease; Atheroma
• Intervention / Treatment: Other: Ultrasound

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 Type: Observational
• Enrollment (Actual): 610

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Kingston, Ontario, Canada, K7L 3N6
      • Queen's University, Cardiovascular Imaging Network at Queen's (CINQ), Kingston General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects referred for outpatient coronary angiography will be screened for inclusion.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cardiac outpatients; Subjects referred for outpatient coronary angiography.	Other: Ultrasound; Contrast-enhanced ultrasound (CEUS); Other Names: Contrast injection - Definity(R)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Dr. Amer Johri
• Collaborators: Lantheus Medical Imaging

Publications and helpful links

Helpful Links

• Cardiovascular Imaging Network at Queen's

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 6, 2016
• Primary Completion (ACTUAL): June 8, 2021
• Study Completion (ACTUAL): January 11, 2022

Study Registration Dates

• First Submitted: February 27, 2018
• First Submitted That Met QC Criteria: March 8, 2018
• First Posted (ACTUAL): March 15, 2018

Study Record Updates

• Last Update Posted (ACTUAL): June 9, 2022
• Last Update Submitted That Met QC Criteria: June 8, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Arteriosclerosis; Arterial Occlusive Diseases; Pathological Conditions, Anatomical; Myocardial Infarction; Infarction; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Atherosclerosis; Acute Coronary Syndrome; Plaque, Atherosclerotic
• Other Study ID Numbers: DMED-1927-16; CG#17006 (OTHER_GRANT: Lantheus Medical Imaging, Inc.); ER15-11-029 (OTHER_GRANT: Ministry of Research, Innovation and Science - Ontario)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No