Recruiting

Florbetaben

Sponsor:

Ottawa Heart Institute Research Corporation

Code:

NCT06091319

Conditions

Acute Coronary Syndrome

Stroke

Transient Ischemic Attack

Atherosclerosis of Artery

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

[18F]-Florbetaben PET and CT imaging

Study Details

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.

Conditions

Acute Coronary Syndrome

Stroke

Transient Ischemic Attack

Atherosclerosis of Artery

Study ID

NCT06091319

Start date

Oct 9, 2023

Status verified date

Sep, 2026

Completion date

Dec 1, 2026

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

Acute atherosclerotic disease event group

Patients with a recent ACS (i.e. STEMI or NSTEMI), stroke or transient ischemic attack.

Control

A control population of patients with known vascular disease but without recent ACS, stroke/TIA.

Interventions

[18F]-Florbetaben PET and CT imaging

\[18F\]-Florbetaben imaging to compare uptake in the culprit and non-culprit arteries.

Primary outcome measure

  • Feasibility of using 18F-Florbetaben PET in patients with recent ACS or stroke/TIA to detect inflammatory plaque [ Time Frame: Within 16 weeks of vascular event ]

Central Contacts and Locations

Central contacts

Locations

University of Ottawa Heart Institute

Recruiting

Ottawa, Ontario, Canada, K1Y 4W7

Contacts

More Information

Sponsor

Ottawa Heart Institute Research Corporation

Last update posted

Sep 8, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ottawa Heart Institute Research Corporation on 2026-09-08.