Carotid Intraplaque Neovascularization Combined With Stress Echo
CIRCE
Combining Intraplaque Neovascularization With Risk Stratification by Carotid Stress ECHO
3 other identifiers
observational
1,500
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2021
Longer than P75 for all trials
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 16, 2021
CompletedFirst Submitted
Initial submission to the registry
June 8, 2022
CompletedFirst Posted
Study publicly available on registry
June 13, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 16, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 16, 2026
February 6, 2025
February 1, 2025
5 years
June 8, 2022
February 3, 2025
Conditions
Keywords
Outcome Measures
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.
This is a 5-year study. The outcome follow up for mace will be 3-years from the index date (SE).
Study Arms (1)
Cardiac outpatients
Subjects referred for outpatient stress echocardiogram (SE).
Interventions
Carotid Contrast-Enhanced Ultrasound (CEUS), a diagnostic ultrasound enhancing agent that opacifies the blood to delineate the vessel walls.
Eligibility Criteria
Low to intermediate risk outpatient subjects referred for stress echo (SE) for assessment of ischemia and risk stratification will be screened for inclusion.
You may qualify if:
- 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.
You may not qualify if:
- 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;
- History of stroke or myocardial infarction (MI);
- Known or documented hypersensitivity or allergy to perflutren (DEFINITY® contrast agent);
- Known or documented allergy to Polyethylene Glycol (Peg) a component of DEFINITY®;
- History of carotid surgery (endarterectomy or stenting);
- Any serious medical condition or complication from the stress test that according to the investigator could interfere with the carotid scan or optimal care;
- Currently pregnant or breastfeeding;
- Previous enrolment into the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dr. Amer Johrilead
- Lantheus Medical Imagingcollaborator
Study Sites (6)
University of Calgary
Calgary, Alberta, T2N 1N4, Canada
University of Alberta
Edmonton, Alberta, T6G 2R3, Canada
Dalhousie University
Halifax, Nova Scotia, B3H 3A7, Canada
The Kingston Heart Clinic
Kingston, Ontario, K7L 1C2, Canada
Queen's University, Cardiovascular Imaging Network at Queen's (CINQ)
Kingston, Ontario, K7L 2V7, Canada
Unity Health Toronto
Toronto, Ontario, M5B 1W8, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amer Johri, MD
Queen's University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 8, 2022
First Posted
June 13, 2022
Study Start
August 16, 2021
Primary Completion (Estimated)
August 16, 2026
Study Completion (Estimated)
August 16, 2026
Last Updated
February 6, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share