Recruiting

Stress Test & Ultrasound

Sponsor:

Dr. Amer Johri

Code:

NCT05416385

Conditions

Atherosclerosis

Cardiovascular Diseases

Acute Coronary Syndrome

Ischemic Heart Disease

Myocardial Infarction

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Carotid Contrast Enhanced Ultrasound

Study Details

Brief 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

Atherosclerosis

Cardiovascular Diseases

Acute Coronary Syndrome

Ischemic Heart Disease

Myocardial Infarction

Study ID

NCT05416385

Start date

Aug 16, 2021

Status verified date

Feb, 2025

Completion date

Aug 16, 2026

Anticipated

Primary completion date

Aug 16, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Men and women >18 years;
2. Referred for a clinically indicated SE for assessment of ischemia and risk stratification;
3. Able and willing to give informed consent.

Exclusion Criteria:

1. Emergency procedure, or active acute coronary syndrome (active chest pain, ischemic electrocardiogram 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), coronary artery bypass graft (GABG), or coronary angioplasty;
5. History of stroke or myocardial infarction (MI);
6. Known or documented hypersensitivity or allergy to perflutren (DEFINITY® contrast agent);
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 to the investigator could interfere with the carotid scan or optimal care;
10. Currently pregnant or breastfeeding;
11. Previous enrolment into the study.

Study Design

Enrollment

1500 participants

Anticipated

Interventions and Outcome Measures

Arms

Cardiac outpatients

Subjects referred for outpatient stress echocardiogram (SE).

Interventions

Carotid Contrast Enhanced Ultrasound

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

Primary outcome measure

  • Our primary outcomes will be the improvement in sensitivity and negative predictive value (NPV). [ Time Frame: This is a 5-year study. The outcome follow up for mace will be 3-years from the index date (SE). ]

Central Contacts and Locations

Central contacts

Locations

University of Calgary

Recruiting

Calgary, Alberta, Canada, T2N 1N4

Principal Investigator:

Omid Kiamanesh, MD

Dalhousie University

Recruiting

Halifax, Nova Scotia, Canada, B3H 3A7

Principal Investigator:

Sharon Mulvagh, MD, FRCPC

The Kingston Heart Clinic

Recruiting

Kingston, Ontario, Canada, K7L 1C2

Contacts

Murray Matangi, MB ChB, FRCPC, FACP, FACC

(613) 544-3242;cinq.research@gmail.com

Principal Investigator:

Murray Matangi, MB ChB, FRCPC, FACP, FACC

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

Recruiting

Kingston, Ontario, Canada, K7L 2V7

Contacts

Unity Health Toronto

Recruiting

Toronto, Ontario, Canada, M5B 1W8

Contacts

Principal Investigator:

Howard Leong-Poi, MD

More Information

Sponsor

Dr. Amer Johri

Last update posted

Feb 6, 2025

Last verified

Feb, 2025

Keywords

  • Ultrasound
  • Echocardiography
  • Stress Testing
  • Contrast Enhanced Ultrasound

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dr. Amer Johri on 2025-02-06.