Acute Coronary SyndromeFERMATANCT06091319
Florbetaben for Imaging of Vascular Amyloid
An observational study of Acute Coronary Syndrome and Stroke, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Coronary Syndrome, Stroke, Transient Ischemic Attack
- What is being tested?
- [18F]-Florbetaben PET and CT imaging
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 9 Oct 2023to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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;.
- unable to give informed consent;.
- Florbetaben allergy;
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7
Chantal L, 6136967000 ext. 18817, clefebvre@ottawaheart.ca
Poppy M, 6136967000 ext. 14646, pmacphee@ottawaheart.ca
About this study
Official title: Florbetaben for Imaging of Vascular Amyloid: Evaluation of Amyloid Inflammasome Imaging in Carotid and Coronary Arteries in Patients With Unstable Atherosclerosis- A Pilot Study
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.
Read the detailed description
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.
- Being tested
- [18F]-Florbetaben PET and CT imaging
- Medical subject headings
- Acute Coronary Syndrome, Stroke, Ischemic Attack, Transient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]-Florbetaben PET and CT imagingProcedure or surgery
[18F]-Florbetaben imaging to compare uptake in the culprit and non-culprit arteries.
| Study group | Role | What they receive |
|---|---|---|
| Acute atherosclerotic disease event group | Patients with a recent ACS (i.e. STEMI or NSTEMI), stroke or transient ischemic attack. Receives: Procedure: [18F]-Florbetaben PET and CT imaging | |
| Control | A control population of patients with known vascular disease but without recent ACS, stroke/TIA. Receives: Procedure: [18F]-Florbetaben PET and CT imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Within 16 weeks of vascular event
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2023
- Study start9 Oct 2023
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Ottawa Heart Institute Research CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Heart Institute Research Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kevin E Boczar, MD, Principal investigator, Ottawa Heart Institute Research Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06091319
- Sponsor's protocol ID
- 20230175-01H
- Acronym
- FERMATA
- Status last verified
- Sep 2026
- First submitted
- 11 Aug 2023
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Florbetaben for Imaging of Vascular Amyloid: Evaluation of Amyloid Inflammasome Imaging in Carotid and Coronary Arteries in Patients With Unstable Atherosclerosis- A Pilot Study
- ClinicalTrials.gov ID
- NCT06091319
- Acronym / sponsor ID
- FERMATA / 20230175-01H
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ottawa Heart Institute Research CorporationUniversity, hospital or other
- Study start
- 9 Oct 2023 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 19 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acute atherosclerotic disease event group | – | Procedure: [18F]-Florbetaben PET and CT imagingPatients with a recent ACS (i.e. STEMI or NSTEMI), stroke or transient ischemic attack. |
| Control | – | Procedure: [18F]-Florbetaben PET and CT imagingA control population of patients with known vascular disease but without recent ACS, stroke/TIA. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [18F]-Florbetaben PET and CT imaging[18F]-Florbetaben imaging to compare uptake in the culprit and non-culprit arteries. | Procedure or surgery | Acute atherosclerotic disease event group, Control |
Primary outcome
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
Ratio of the standardized uptake value (SUV) of Florbetaben tracer to the background (SVC or internal jugular for coronary or carotid respectively)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kevin E Boczar, MD principal investigator
Ottawa Heart Institute Research Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome and Stroke, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kevin E Boczar, MD (6132821835, kboczar@ottawaheart.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.