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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06091319
Other study ID # 1.0
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 9, 2023
Est. completion date August 1, 2025

Study information

Verified date May 2024
Source Ottawa Heart Institute Research Corporation
Contact Kevin E Boczar, MD
Phone 6132821835
Email kboczar@ottawaheart.ca
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date August 1, 2025
Est. primary completion date August 1, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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


Locations

Country Name City State
Canada University of Ottawa Heart Institute Ottawa Ontario

Sponsors (1)

Lead Sponsor Collaborator
Ottawa Heart Institute Research Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Other 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
Other 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
Primary 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
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