Florbetaben for Imaging of Vascular Amyloid (FERMATA)

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Transient Ischemic Attack; Acute Coronary Syndrome; Atherosclerosis of Artery
• Intervention / Treatment: Procedure: [18F]-Florbetaben PET and CT imaging

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 Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Kevin E Boczar, MD; Phone Number: 6132821835; Email: kboczar@ottawaheart.ca

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1Y 4W7
      • Recruiting
      • University of Ottawa Heart Institute
      • Contact: Chantal L; Phone Number: 18817 6136967000; Email: clefebvre@ottawaheart.ca
      • Contact: Poppy M; Phone Number: 14646 6136967000; Email: pmacphee@ottawaheart.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Acute atherosclerotic disease event group; Patients with a recent ACS (i.e. STEMI or NSTEMI), stroke or transient ischemic attack.	Procedure: [18F]-Florbetaben PET and CT imaging; [18F]-Florbetaben imaging to compare uptake in the culprit and non-culprit arteries.
Control; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Within 16 weeks of vascular event

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	Within 16 weeks of vascular event

Collaborators and Investigators

• Sponsor: Ottawa Heart Institute Research Corporation
• Investigators: Principal Investigator: Kevin E Boczar, MD, Ottawa Heart Institute Research Corporation

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2023
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: August 11, 2023
• First Submitted That Met QC Criteria: October 13, 2023
• First Posted (Actual): October 19, 2023

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Brain Ischemia; Myocardial Ischemia; Stroke; Ischemic Attack, Transient; Acute Coronary Syndrome
• Other Study ID Numbers: 20230175-01H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No