Florbetaben for Imaging of Vascular Amyloid

Launched by OTTAWA HEART INSTITUTE RESEARCH CORPORATION · Oct 13, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new imaging technique using a special tracer called 18F-Florbetaben to help doctors see inflamed plaque in the blood vessels of patients who have recently experienced a heart attack or stroke. The goal is to see if this new method can improve how we understand and treat conditions like acute coronary syndrome and atherosclerosis (narrowing of the arteries caused by plaque buildup).

To be eligible for the trial, participants must be at least 18 years old and have had a recent cardiovascular event, such as a heart attack or stroke, within the last 30 to 120 days. They should also be stable in their health and able to provide informed consent. Throughout the study, participants will undergo imaging tests, and those who qualify will receive close monitoring. It's important to note that certain individuals, such as those with specific heart conditions or who are pregnant, may not be eligible. This study is currently recruiting participants, and anyone interested should discuss it with their healthcare provider for more information.

Gender

ALL

Eligibility criteria

• 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.