Carotid Intraplaque Neovascularization Combined with Stress Echo

Last updated: February 3, 2025
Sponsor: Dr. Amer Johri
Overall Status: Active - Recruiting

Phase

N/A

Condition

Atherosclerosis

Coronary Artery Disease

Congestive Heart Failure

Treatment

Carotid Contrast Enhanced Ultrasound

Clinical Study ID

NCT05416385
DMED-2469-21-6032717
CG#21007
452696
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Men and women >18 years;

  2. Referred for a clinically indicated SE for assessment of ischemia and riskstratification;

  3. Able and willing to give informed consent.

Exclusion

Exclusion Criteria:

  1. Emergency procedure, or active acute coronary syndrome (active chest pain, ischemicelectrocardiogram changes, or cardiac enzyme elevation);

  2. Referral for viability, pulmonary hypertension, or valve assessment;

  3. Referral outside of the normal working hours;

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

  5. History of stroke or myocardial infarction (MI);

  6. Known or documented hypersensitivity or allergy to perflutren (DEFINITY® contrastagent);

  7. Known or documented allergy to Polyethylene Glycol (Peg) a component of DEFINITY®;

  8. History of carotid surgery (endarterectomy or stenting);

  9. Any serious medical condition or complication from the stress test that according tothe investigator could interfere with the carotid scan or optimal care;

  10. Currently pregnant or breastfeeding;

  11. Previous enrolment into the study.

Study Design

Total Participants: 1500
Treatment Group(s): 1
Primary Treatment: Carotid Contrast Enhanced Ultrasound
Phase:
Study Start date:
August 16, 2021
Estimated Completion Date:
August 16, 2026

Study Description

Primary Aim: To determine if carotid intraplaque neovascularization score (IPN) combined with stress echo (SE) [IPN+SE] enhances prediction of 3-year major adverse cardiovascular events (MACE) compared to SE alone.

Objectives: 1) The % change in test sensitivity of IPN+SE for predicting 3-year MACE compared with SE alone. 2) The Net Reclassification Improvement (NRI) for MACE will be determined (patients "missed" by the SE, but captured as high risk for MACE by IPN).

Connect with a study center

  • University of Calgary

    Calgary, Alberta T2N 1N4
    Canada

    Active - Recruiting

  • University of Alberta

    Edmonton, Alberta T6G 2R3
    Canada

    Site Not Available

  • Dalhousie University

    Halifax, Nova Scotia B3H 3A7
    Canada

    Active - Recruiting

  • Queen's University, Cardiovascular Imaging Network at Queen's (CINQ)

    Kingston, Ontario K7L 2V7
    Canada

    Active - Recruiting

  • The Kingston Heart Clinic

    Kingston, Ontario K7L 1C2
    Canada

    Active - Recruiting

  • Unity Health Toronto

    Toronto, Ontario M5B 1W8
    Canada

    Active - Recruiting

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