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Carotid Intraplaque Neovascularization Combined With Stress Echo

Recruitingn/aAges 18 Years - anyAllDr. Amer Johri
NCT05416385 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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.
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What it tests

  • Carotid Contrast Enhanced Ultrasound
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Where

6 sites
University of Calgary
Calgary, Canada
University of Alberta
Edmonton, Canada
Dalhousie University
Halifax, Canada
The Kingston Heart Clinic
Kingston, Canada
Queen's University, Cardiovascular Imaging Network at Queen's (CINQ)
Kingston, Canada
Unity Health Toronto
Toronto, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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