An observational study in Acute Coronary Syndrome, Stroke and Transient Ischemic Attack, sponsored by Ottawa Heart Institute Research Corporation. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by Ottawa Heart Institute Research Corporation · Observational
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.
The Primary Objective is to determine the feasibility of using 18F-Florbetaben PET in patients with recent ACS or stroke/TIA to detect inflammatory plaque.
Exploratory Objectives will define relationships of calcification imaging to other biomarkers and comparisons between high and low plaque burden regions and between patients with and without recent vascular events.
Patients with a recent ACS (i.e. STEMI or NSTEMI), stroke or transient ischemic attack (TIA) will be recruited will be recruited to the FERMATA study. A control population of patients with known vascular disease but without recent ACS, stroke/TIA will also be recruited.
FERMATA is a pilot, single- centerre, imaging study. We will evaluate the ability of the amyloid tracer, 18F-Florbetaben, to detect active atherosclerotic plaque in patients with recent ACS, or recent TIA/stroke. We plan to enroll 24 patients with ACS or patients with stroke/TIA and 6 control patients without recent ACS or stroke/TIA. Primary endpoint is the difference in Florbetaben uptake between the culprit artery (of either the ACS or TIA/stroke, respectively), and the non-culprit arteries. Parameters of interest are the maximal and total standard uptake values (SUVs) and tissue-to- background ratios (TBRs) of the coronary and carotid arteries as well as aorta.
Exploratory endpoints include a correlation analysis (Pearson correlation) to evaluate the relationship of inflammation on Florbetaben PET/CT to the histopathological levels of inflammation. In addition, we will look to see if Florbetaben uptake on PET correlates with lesion levels of B-amyloid. Comparisons will also be made between regions of high plaque burden vs lower plaque burden and between patients with recent vascular events vs those who have not had recent events.
1,488 studies on the registry are indexed under Acute Coronary Syndrome; 273 are open to participants now.
This study's planned enrollment of 30 is below the median of 500 across 590 observational studies indexed under Acute Coronary Syndrome.
Browse Acute Coronary Syndrome studies →Ottawa Heart Institute Research Corporation is the lead sponsor of 182 studies on the registry; 42 are open to participants now.
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Patients with a recent ACS (i.e. STEMI or NSTEMI), stroke or transient ischemic attack (TIA) will be recruited. Standard definitions will be used for STEMI, NSTEMI including chest pain, EKG changes and troponin rise; likewise for ischemic stroke confirmed by CT or MRI imaging and TIA confirmed as a definite by a neurologist.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with a recent ACS (i.e. STEMI or NSTEMI), stroke or transient ischemic attack.
Procedure: [18F]-Florbetaben PET and CT imaging
A control population of patients with known vascular disease but without recent ACS, stroke/TIA.
Procedure: [18F]-Florbetaben PET and CT imaging
\[18F\]-Florbetaben imaging to compare uptake in the culprit and non-culprit arteries.
Feasibility of using 18F-Florbetaben PET in patients with recent ACS or stroke/TIA to detect inflammatory plaque
Ratio of the standardized uptake value (SUV) of Florbetaben tracer to the background (SVC or internal jugular for coronary or carotid respectively)
Time frame: Within 16 weeks of vascular event
TBR of arteries in acute patients compared to control patients
Tissue to background (TBR) of arteries in patients with acute vascular events compared to TBR in arteries of control patients
Time frame: Within 16 weeks of vascular event
TBR of arteries in with higher plaque burden compared to lower plaque burden
Tissue to background (TBR) of arteries in patients with higher plaque burden on CT compared to TBR in arteries of lower plaque burden
Time frame: Within 16 weeks of vascular event
Plan to share: Undecided
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