NCT05416385 Carotid Intraplaque Neovascularization Combined With Stress Echo
| NCT ID | NCT05416385 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Dr. Amer Johri |
| Condition | Atherosclerosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,500 participants |
| Start Date | 2021-08-16 |
| Primary Completion | 2026-08-16 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,500 participants in total. It began in 2021-08-16 with a primary completion date of 2026-08-16.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Amer Johri, MD
PRINCIPAL INVESTIGATOR
Queen's University
Frequently Asked Questions
Who can join the NCT05416385 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Atherosclerosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05416385 currently recruiting?
Yes, NCT05416385 is actively recruiting participants. Contact the research team at cinq.research@gmail.com for enrollment information.
Where is the NCT05416385 trial being conducted?
This trial is being conducted at Calgary, Canada, Edmonton, Canada, Halifax, Canada, Kingston, Canada and 2 additional locations.
Who is sponsoring the NCT05416385 clinical trial?
NCT05416385 is sponsored by Dr. Amer Johri. The principal investigator is Amer Johri, MD at Queen's University. The trial plans to enroll 1,500 participants.