Using a new imaging agent to detect inflamed plaque in heart and brain patients
Florbetaben for Imaging of Vascular Amyloid: Evaluation of Amyloid Inflammasome Imaging in Carotid and Coronary Arteries in Patients With Unstable Atherosclerosis- A Pilot Study
This study is testing a new imaging agent to see if it can help spot inflamed plaque in patients who have recently had a heart attack or stroke.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ottawa Heart Institute Research Corporation Academic / other |
| Locations | 1 site (Ottawa, Ontario) |
| Trial ID | NCT06091319 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the feasibility of using the nuclear tracer 18F-Florbetaben with PET imaging to identify inflammatory plaque in patients who have recently experienced acute coronary syndrome (ACS) or a stroke/transient ischemic attack (TIA). The study will enroll 24 patients with recent cardiovascular events and 6 control patients with known vascular disease but without recent events. Primary endpoints include measuring the uptake of Florbetaben in culprit versus non-culprit arteries, while exploratory objectives will assess correlations with other biomarkers and plaque burden. The study is conducted at a single center, the University of Ottawa Heart Institute.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have suffered a recent cardiovascular event such as ACS or stroke/TIA.
Not a fit: Patients with recent embolic events, severe heart dysfunction, or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the detection and management of inflammatory plaque in patients at risk for cardiovascular events.
How similar studies have performed: While this approach is novel in the context of using 18F-Florbetaben for this specific purpose, similar imaging techniques have shown promise in detecting vascular inflammation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 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; 2. stable symptoms and hemodynamics; 3. age \>/= 18 years; 4. given informed consent. Exclusion Criteria: 1. a recent CV event likely to have been embolic in the opinion of the neurologist or cardiologist; 2. severe LV dysfunction (EF\<30%); 3. severe valve disease requiring intervention; 4. decompensated heart failure; 5. pregnancy (all women of child bearing potential will have a negative BHCG test; 6. breastfeeding; 7. 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;. 8. unable to give informed consent;. 9. Florbetaben allergy; 10. 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 this trial is running
Ottawa, Ontario
- University of Ottawa Heart Institute — Ottawa, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Kevin E Boczar, MD — Ottawa Heart Institute Research Corporation
- Study coordinator: Kevin E Boczar, MD
- Email: kboczar@ottawaheart.ca
- Phone: 6132821835
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.