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Florbetaben for Imaging of Vascular Amyloid
RECRUITINGSponsored by Ottawa Heart Institute Research Corporation
Actively Recruiting
SponsorOttawa Heart Institute Research Corporation
Started2023-10-09
Est. completion2025-08-01
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06091319
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.
Eligibility
Age: 18 Years+Healthy volunteers accepted
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.
Conditions5
Acute Coronary SyndromeAtherosclerosis of ArteryHeart DiseaseStrokeTransient Ischemic Attack
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Actively Recruiting
SponsorOttawa Heart Institute Research Corporation
Started2023-10-09
Est. completion2025-08-01
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06091319