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Carotid Intraplaque Neovascularization Combined With Stress Echo

NCT05416385 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1500

Last updated 2025-02-06

No results posted yet for this study

Summary

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.

Conditions

Interventions

OTHER

Carotid Contrast Enhanced Ultrasound

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

Sponsors & Collaborators

  • Lantheus Medical Imaging

    collaborator INDUSTRY

  • Dr. Amer Johri

    lead OTHER

Principal Investigators

  • Amer Johri, MD · Queen's University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-16
Primary Completion
2026-08-16
Completion
2026-08-16

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05416385 on ClinicalTrials.gov