Status:
RECRUITING
Carotid Intraplaque Neovascularization Combined With Stress Echo
Lead Sponsor:
Dr. Amer Johri
Collaborating Sponsors:
Lantheus Medical Imaging
Conditions:
Atherosclerosis
Cardiovascular Diseases
Eligibility:
All Genders
18+ years
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...
Detailed Description
Primary Aim: To determine if carotid intraplaque neovascularization score (IPN) combined with stress echo (SE) \[IPN+SE\] enhances prediction of 3-year major adverse cardiovascular events (MACE) compa...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
August 16 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 16 2026
Estimated Enrollment :
1500 Patients enrolled
Trial Details
Trial ID
NCT05416385
Start Date
August 16 2021
End Date
August 16 2026
Last Update
February 6 2025
Active Locations (6)
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1
University of Calgary
Calgary, Alberta, Canada, T2N 1N4
2
University of Alberta
Edmonton, Alberta, Canada, T6G 2R3
3
Dalhousie University
Halifax, Nova Scotia, Canada, B3H 3A7
4
The Kingston Heart Clinic
Kingston, Ontario, Canada, K7L 1C2