Stroke Clinical Trial
— FERMATAOfficial 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
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 |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Canada | University of Ottawa Heart Institute | Ottawa | Ontario |
Lead Sponsor | Collaborator |
---|---|
Ottawa Heart Institute Research Corporation |
Canada,
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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