Assessing heart disease risk using carotid ultrasound and stress tests
Combining Intraplaque Neovascularization With Risk Stratification by Carotid Stress ECHO
This study is testing if combining a special ultrasound of the neck with stress tests can better identify people at risk for serious heart problems over the next three years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Queen's University Academic / other |
| Locations | 6 sites (Calgary, Alberta and 5 other locations) |
| Trial ID | NCT05416385 on ClinicalTrials.gov |
What this trial studies
This observational study aims to improve the accuracy of stress tests in predicting major cardiovascular events by combining carotid intraplaque neovascularization scoring with stress echocardiography. The primary objective is to evaluate whether this combined approach enhances the prediction of three-year major adverse cardiovascular events compared to stress echocardiography alone. By analyzing the percentage change in test sensitivity and the net reclassification improvement, the study seeks to identify patients at higher risk who may otherwise be missed by standard stress tests. The interventions involve the use of carotid contrast-enhanced ultrasound to assess plaque characteristics.
Who should consider this trial
Good fit: Ideal candidates include men and women over 18 years old who are referred for a clinically indicated stress echocardiogram for assessment of ischemia and risk stratification.
Not a fit: Patients with active acute coronary syndrome, significant coronary artery disease history, or those requiring emergency procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate risk assessments for heart disease, potentially reducing the incidence of heart attacks and other major cardiovascular events.
How similar studies have performed: While the approach of combining imaging techniques is not widely tested, similar studies have shown promise in enhancing cardiovascular risk stratification.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Calgary, Alberta and 5 other locations
- University of Calgary — Calgary, Alberta, Canada (Recruiting)
- University of Alberta — Edmonton, Alberta, Canada (Not_yet_recruiting)
- Dalhousie University — Halifax, Nova Scotia, Canada (Recruiting)
- The Kingston Heart Clinic — Kingston, Ontario, Canada (Recruiting)
- Queen's University, Cardiovascular Imaging Network at Queen's (CINQ) — Kingston, Ontario, Canada (Recruiting)
- Unity Health Toronto — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Amer Johri, MD — Queen's University
- Study coordinator: Marie-France Hetu, PhD
- Email: cinq.research@gmail.com
- Phone: 1 613-549-6666
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.