Actively Recruiting
Florbetaben for Imaging of Vascular Amyloid: Evaluation of Amyloid Inflammasome Imaging in Carotid and Coronary Arteries in Patients With Unstable Atherosclerosis - A Pilot Study
Led by Ottawa Heart Institute Research Corporation · Updated on 2026-05-08
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether a new nuclear tracer called 18F-Florbetaben, used with PET imaging, can detect inflamed plaque in patients who recently experienced acute coronary syndrome (ACS) or stroke/transient ischemic attack (TIA). This pilot imaging study aims to assess the tracer's ability to identify active atherosclerotic plaque in these patients, comparing uptake in affected arteries to non-affected arteries. Exploratory goals include studying relationships between plaque calcification, other biomarkers, and differences in plaque burden and recent vascular events. The study involves two groups: patients with a recent ACS (including STEMI or NSTEMI), stroke, or TIA; and a control group with known vascular disease but no recent ACS or stroke/TIA. Participants will undergo 18F-Florbetaben PET and CT imaging to compare tracer uptake in culprit versus non-culprit arteries. Parameters such as standard uptake values and tissue-to-background ratios will be measured in coronary, carotid arteries, and the aorta. Additional imaging with CTA will be performed unless contraindicated. Participants will be assessed within 16 weeks of their vascular event. Researchers will collect imaging data and analyze correlations to histopathological inflammation and amyloid levels. Safety and feasibility are monitored throughout. The study plans to enroll 24 recent event patients and 6 controls. Participation includes imaging procedures, consent, and clinical stability assessments, lasting through the imaging and analysis phases.
CONDITIONS
Brief Title
Florbetaben for Imaging of Vascular Amyloid
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Recent cardiovascular event 30 to 120 days ago (ACS including STEMI or NSTEMI, or TIA/stroke with ipsilateral large vessel atherosclerotic disease confirmed by imaging)
- Stable symptoms and hemodynamics
- Age 18 years or older
- Given informed consent
You will not qualify if you...
- Recent cardiovascular event likely embolic in opinion of neurologist or cardiologist
- Severe left ventricular dysfunction with ejection fraction below 30%
- Severe valve disease requiring intervention
- Decompensated heart failure
- Pregnancy or breastfeeding
- Women of childbearing potential refusing to use two forms of contraception during the study
- Men capable of fathering a child refusing to use contraception
- Unable to give informed consent
- Allergy to Florbetaben
- Glomerular filtration rate less than 50 ml/min/1.72m2
- For CTA imaging: dye allergy or GFR less than 60 (these patients will not have CTA but will have PET/CT)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 16 weeks after vascular event
Participants undergo 18F-Florbetaben PET and CT imaging to detect inflammatory plaque in arteries and compare uptake in culprit and non-culprit arteries.
1 imaging visit (in-person)
Trial Site Locations
Total: 1 location
1
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7
Actively Recruiting
Research Team
K
Kevin E Boczar, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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