Florbetaben for Imaging of Vascular Amyloid

NCT06091319 | Recruiting

• 1 other identifier: 1.0
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Coronary Syndrome; Stroke; Transient Ischemic Attack; Atherosclerosis of Artery

Outcome Measures

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)

  Within 16 weeks of vascular event

Other Outcomes (2)

• TBR of arteries in acute patients compared to control patients

  Within 16 weeks of vascular event

• TBR of arteries in with higher plaque burden compared to lower plaque burden

  Within 16 weeks of vascular event

Study Arms (2)

Acute atherosclerotic disease event group

Patients with a recent ACS (i.e. STEMI or NSTEMI), stroke or transient ischemic attack.

Control

A control population of patients with known vascular disease but without recent ACS, stroke/TIA.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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;
• pregnancy (all women of child bearing potential will have a negative BHCG test;
• breastfeeding;
• 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;.
• unable to give informed consent;.
• Florbetaben allergy;
• glomerular filtration rate (GFR) \<50 ml/min/1.72m2

Sponsors & Collaborators

• Ottawa Heart Institute Research Corporation: lead

Study Sites (1)

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

RECRUITING

MeSH Terms

Conditions

Acute Coronary Syndrome; Stroke; Ischemic Attack, Transient

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia

Study Officials

• Kevin E Boczar, MD

  Ottawa Heart Institute Research Corporation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kevin E Boczar, MD

CONTACT

6132821835; kboczar@ottawaheart.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2023
• First Posted: October 19, 2023
• Study Start: October 9, 2023
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 30, 2026

Record last verified: 2026-04

Locations

CA (1)