RECRUITINGOBSERVATIONAL
Florbetaben for Imaging of Vascular Amyloid
Florbetaben for Imaging of Vascular Amyloid: Evaluation of Amyloid Inflammasome Imaging in Carotid and Coronary Arteries in Patients With Unstable Atherosclerosis- A Pilot Study
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.
Who May Be Eligible (Plain English)
Who May Qualify:
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 willing to sign a consent form.
Who Should NOT Join This Trial:
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 willing to sign a consent form;.
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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Locations (1)
University of Ottawa Heart Institute
Ottawa, Ontario, Canada