Florbetaben for Imaging of Vascular Amyloid
Recruiting now
Conditions studied: Acute Coronary Syndrome, Stroke, Transient Ischemic Attack, Atherosclerosis of Artery
In brief
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.
Key facts
- Study ID
- NCT06091319
- Run by
- Ottawa Heart Institute Research Corporation
- People needed
- 30
- Starts
- 2023-10-09
- Expected to finish
- 2026-08-01
- Last updated by the study team
- 2026-05-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- University of Ottawa Heart Institute — Ottawa, Ontario, Canada (enrolling)
Full record on ClinicalTrials.gov
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