Skip to main content
OpenTrials
Completed

NCT Number: NCT03466255

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Atheroma Acute Coronary Syndrome Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiac Disease Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Plaque, Atherosclerotic Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Kingston, Ontario, K7L 3N6, Canada

About this study

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

  • 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
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • >18 years of age
  • Outpatients referred for clinically indicated angiography for assessment of CAD
  • Low - Intermediate Framingham risk (<20%)
  • Absence of clinical contraindication to angiography
  • Able and willing to give informed consent

Exclusion criteria

  • Patients presenting with acute coronary syndrome
  • Patients with previously known significant CAD (any lesion >50%) or percutaneous coronary intervention or coronary artery bypass surgery
  • Previous carotid surgery or angioplasty
  • Documented allergy to echo contrast

Treatment and study plan

ultrasound

Other

Contrast-enhanced ultrasound (CEUS)

Other names: Contrast injection - Definity(R)

Primary outcomes

  1. Maximum Plaque Height (physiological parameter)

    Time frame: 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.

  2. Total Plaque Area (physiological parameter)

    Time frame: 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.

  3. Neovascularization (contrast enhancement intensity) (physiological parameter)

    Time frame: 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.

  4. Contrast wash-in time (physiological parameter)

    Time frame: 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 outcomes

  1. Participants CV outcome follow-up (data linkage through the Institute for Clinical Evaluative Sciences: ICES)

    Time frame: 5 years

    Participants will be followed for major adverse cardiac event over 5 years. Number of events will be correlated to carotid plaque measurements.

Sponsors and collaborators

Lead sponsor

Dr. Amer Johri

Other

Collaborators

  • Lantheus Medical Imaging

Registry information

Official study title

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

Acronym: VIBE

Important dates

Study start
2016
Primary completion
2021
Study completion
2022
First posted
Mar 15, 2018
Registry last updated
Jun 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.