Ignite Creation Date:
2024-05-06 @ 7:40 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06091319
Status:
RECRUITING
Last Update Posted:
2024-05-29
First Post:
2023-08-11
Brief Title:
Florbetaben for Imaging of Vascular Amyloid
Sponsor:
Ottawa Heart Institute Research Corporation
Organization:
Ottawa Heart Institute Research Corporation
Study Overview
Official Title:
Florbetaben for Imaging of Vascular Amyloid Evaluation of Amyloid Inflammasome Imaging in Carotid and Coronary Arteries in Patients With Unstable Atherosclerosis- A Pilot Study
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FERMATA
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 strokeTIA
Detailed Description:
The Primary Objective is to determine the feasibility of using 18F-Florbetaben PET in patients with recent ACS or strokeTIA to detect inflammatory plaque
Exploratory Objectives will define relationships of calcification imaging to other biomarkers and comparisons between high and low plaque burden regions and between patients with and without recent vascular events
Patients with a recent ACS ie STEMI or NSTEMI stroke or transient ischemic attack TIA will be recruited will be recruited to the FERMATA study A control population of patients with known vascular disease but without recent ACS strokeTIA will also be recruited
FERMATA is a pilot single- centerre imaging study We will evaluate the ability of the amyloid tracer 18F-Florbetaben to detect active atherosclerotic plaque in patients with recent ACS or recent TIAstroke We plan to enroll 24 patients with ACS or patients with strokeTIA and 6 control patients without recent ACS or strokeTIA Primary endpoint is the difference in Florbetaben uptake between the culprit artery of either the ACS or TIAstroke respectively and the non-culprit arteries Parameters of interest are the maximal and total standard uptake values SUVs and tissue-to- background ratios TBRs of the coronary and carotid arteries as well as aorta
Exploratory endpoints include a correlation analysis Pearson correlation to evaluate the relationship of inflammation on Florbetaben PETCT to the histopathological levels of inflammation In addition we will look to see if Florbetaben uptake on PET correlates with lesion levels of B-amyloid Comparisons will also be made between regions of high plaque burden vs lower plaque burden and between patients with recent vascular events vs those who have not had recent events
Exploratory Objectives will define relationships of calcification imaging to other biomarkers and comparisons between high and low plaque burden regions and between patients with and without recent vascular events
Patients with a recent ACS ie STEMI or NSTEMI stroke or transient ischemic attack TIA will be recruited will be recruited to the FERMATA study A control population of patients with known vascular disease but without recent ACS strokeTIA will also be recruited
FERMATA is a pilot single- centerre imaging study We will evaluate the ability of the amyloid tracer 18F-Florbetaben to detect active atherosclerotic plaque in patients with recent ACS or recent TIAstroke We plan to enroll 24 patients with ACS or patients with strokeTIA and 6 control patients without recent ACS or strokeTIA Primary endpoint is the difference in Florbetaben uptake between the culprit artery of either the ACS or TIAstroke respectively and the non-culprit arteries Parameters of interest are the maximal and total standard uptake values SUVs and tissue-to- background ratios TBRs of the coronary and carotid arteries as well as aorta
Exploratory endpoints include a correlation analysis Pearson correlation to evaluate the relationship of inflammation on Florbetaben PETCT to the histopathological levels of inflammation In addition we will look to see if Florbetaben uptake on PET correlates with lesion levels of B-amyloid Comparisons will also be made between regions of high plaque burden vs lower plaque burden and between patients with recent vascular events vs those who have not had recent events
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None