Using a new imaging agent to detect inflamed plaque in heart and brain patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.