Status:
RECRUITING
Florbetaben for Imaging of Vascular Amyloid
Lead Sponsor:
Ottawa Heart Institute Research Corporation
Conditions:
Acute Coronary Syndrome
Stroke
Eligibility:
All Genders
18+ years
Brief Summary
The Primary Objective is to determine if a new nuclear tracer (named 18F-Florbetaben) used with nuclear imaging (PET imaging) can detect inflamed plaque in patients with recent ACS or stroke/TIA.
Detailed Description
The Primary Objective is to determine the feasibility of using 18F-Florbetaben PET in patients with recent ACS or stroke/TIA to detect inflammatory plaque. Exploratory Objectives will define relation...
Eligibility Criteria
Inclusion
- suffered a recent cardiovascular event (30-120 days post ACS (i.e. STEMI or NSTEMI) or TIA/stroke with ipsilateral large vessel atherosclerotic disease confirmed on US, CT or MRI;
- stable symptoms and hemodynamics;
- age \>/= 18 years;
- given informed consent.
Exclusion
- a recent CV event likely to have been embolic in the opinion of the neurologist or cardiologist;
- severe LV dysfunction (EF\<30%);
- severe valve disease requiring intervention;
- decompensated heart failure;
- pregnancy (all women of child bearing potential will have a negative BHCG test;
- breastfeeding;
- women of childbearing potential who refuse to use two forms of contraception (this includes at least one form of highly effective and one effective method of contraception) throughout the study OR men capable of fathering a child who refuse to use contraception;.
- unable to give informed consent;.
- Florbetaben allergy;
- glomerular filtration rate (GFR) \<50 ml/min/1.72m2
- Exclusion for CTA portion of the protocol: Patients with dye allergy, or those with GFR \<60, will not undergo CTA but will have PET/CT.
Key Trial Info
Start Date :
October 9 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06091319
Start Date
October 9 2023
End Date
August 1 2025
Last Update
May 29 2024
Active Locations (1)
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1
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7