RecruitingNot Applicable

Florbetaben for Imaging of Vascular Amyloid

Canada30 participantsStarted 2023-10-09

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Exclusion criteria

. 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;.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Feasibility of using 18F-Florbetaben PET in patients with recent ACS or stroke/TIA to detect inflammatory plaque

Timeframe: Within 16 weeks of vascular event

Trial details

NCT IDNCT06091319

SponsorOttawa Heart Institute Research Corporation

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-08-01

Contact for this trial

Kevin E Boczar, MD

6132821835 kboczar@ottawaheart.ca

View on ClinicalTrials.gov More Acute Coronary Syndrome trials