Carotid Intraplaque Neovascularization Combined With Stress Echo

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorDr. Amer Johri

About this trial

The root cause of heart attacks and strokes is atherosclerosis, the hardening and thickening of blood vessels due to the presence of "plaque" which is a build-up of fat and cholesterol in the walls of vessels. To diagnose heart disease, patients receive a stress test to find out if they require surgery. Up to 52% of patients receiving an angiogram (surgery) to look at plaque blockages in the heart are found to be normal (no blockage). Patients who are suspected of having heart disease often undergo a stress test, which helps cardiologists decide if the patient has heart disease, but stress tests can give false results. In Ontario alone, 90% are stress tests are found to be normal and patients are sent home with little follow-up. Of these 3-5% (\~4,000 patients/year) will have a major cardiovascular event (heart attack, surgery, or death) within 3 years. We need to improve the stress test accuracy to reduce cardiac outcome. We now know that it is not just the total amount of plaque that leads to heart attacks and strokes, but the composition of the plaque that can lead to breakage causing a heart attack. Plaques are soft and fragile, and typically contain fat and small leaky blood vessels within their cores. If we are able to identify patients that have leaky plaques using ultrasound, we may be able to improve the accuracy of stress testing. We propose a study looking at the combination of stress testing (assessing heart function) and neck ultrasound (assessing plaque composition), to identify patients at risk for cardiovascular events (heart attacks and death). We will enrol patients from 6 sites across Canada and follow-them for cardiac outcome for 3 years.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Men and women >18 years;

Referred for a clinically indicated SE for assessment of ischemia and risk stratification;

Able and willing to give informed consent.

Disqualifiers

Emergency procedure, or active acute coronary syndrome (active chest pain, ischemic electrocardiogram changes, or cardiac enzyme elevation);

Referral for viability, pulmonary hypertension, or valve assessment;

Referral outside of the normal working hours;

History of significant CAD: percutaneous coronary intervention (PCI), coronary artery bypass graft (GABG), or coronary angioplasty;

Trial population

Low to intermediate risk outpatient subjects referred for stress echo (SE) for assessment of ischemia and risk stratification will be screened for inclusion.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Carotid Contrast Enhanced Ultrasound

    Other intervention

    Carotid Contrast-Enhanced Ultrasound (CEUS), a diagnostic ultrasound enhancing agent that opacifies the blood to delineate the vessel walls.

Treatment groups

1,500 Participants
are divided into 1 treatment group
Group A: Cardiac outpatients1 intervention

Trial outcomes

Primary outcomes

1

Our primary outcomes will be the improvement in sensitivity and negative predictive value (NPV).

Our primary analysis will compare the sensitivity of an established binary test based on SE alone to a binary test based on SE and plaque assessment (using established thresholds, IPN≥1.25) to predict 3-year MACE.

Time frame
This is a 5-year study. The outcome follow up for mace will be 3-years from the index date (SE).

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dr. Amer Johri

Lead sponsor

Queen's University

Sponsor institution

Lantheus Medical Imaging

Collaborator