Florbetaben for Imaging of Vascular Amyloid
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorOttawa Heart Institute Research Corporation
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
[18F]-Florbetaben PET and CT imaging
Procedure/Surgery\[18F\]-Florbetaben imaging to compare uptake in the culprit and non-culprit arteries.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Acute atherosclerotic disease event group1 intervention
Group B: Control1 intervention
Trial outcomes
Primary outcomes
1
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)
Time frame
Within 16 weeks of vascular eventOther outcomes
1
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
Time frame
Within 16 weeks of vascular event2
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
Time frame
Within 16 weeks of vascular eventSponsors and contacts
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Source ClinicalTrials.gov