PROFILE-MI - The FAPI Fibrosis Study
May 16, 2024 updated by: University of Edinburgh
PROline and FapI With Late Gadolinium Enhancement in Myocardial Infarction PROFILE-MI - The FAPI Fibrosis Study
The investigators here propose to investigate the timing and pattern of myocardial fibrosis activity following acute myocardial infarction using hybrid 68Ga-FAPI positron emission tomography and cardiovascular magnetic resonance.
The investigators hypothesise that peak fibrosis activity will occur within 2-4 weeks of acute myocardial infarction and will predict subsequent scar formation and cardiac remodelling.
Simultaneously, matrix remodelling and fibrosis activity in aortic and coronary atheroma will be assessed enabling the exploration of the presence of unstable atheroma.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Fibrosis is a fundamental process underlying almost all cardiomyopathic conditions.
Established fibrosis can be detected by existing imaging techniques including cardiovascular magnetic resonance.
However, these techniques are not specific for fibrosis and do not directly measure fibrosis activity or matrix remodelling.
This limits the ability to detect early disease and differentiate active from end-stage phenotypes.
Fibroblast activation protein is a key factor in fibrogenesis that is expressed in the myocardium following myocardial infarction and in thin-capped fibroatheroma.
Radiolabelled fibroblast activation protein inhibitor (68Ga-FAPI) measures in vivo fibrosis activity and matrix remodelling, as supported by preliminary pilot studies.
The timing and pattern of myocardial fibrosis activity following acute myocardial infarction will be investigated using hybrid 68Ga-FAPI positron emission tomography.
The investigators hypothesise that peak fibrosis activity will occur within 2-4 weeks of acute myocardial infarction and will predict subsequent scar formation and cardiac remodelling.
Simultaneously, matrix remodelling and fibrosis activity in aortic and coronary atheroma will also be assessed allowing exploration of the presence of unstable atheroma.
This project will enhance understanding of fibrosis activity and matrix remodelling in myocardial infarction and unstable atherosclerotic plaque with potential future application to a broad range of cardiovascular diseases.
Study Type
Observational
Enrollment (Actual)
80
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
City Of Edinburgh
-
Edinburgh, City Of Edinburgh, United Kingdom, EH16 4SA
- Royal Infirmary of Edinburgh
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Healthy volunteer participants (cohort 1, n=20): those without significant or serious comordibity or known cardiac disease
Participants with acute myocardial infarction (cohorts 2 and 3, n=40): ST-elevation myocardial infarction within 3 weeks of enrollment
Participants with chronic myocardial infarction (n=20): ST-elevation myocardial infarction 24 months or more prior to enrollment
Description
Inclusion Criteria:
- specific to cohort;
- aged 50 years or older
Exclusion Criteria:
- Claustrophobia
- Inability to undergo MRI
- eGFR <30ml/min/1.73^m2
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Healthy volunteers
Age- and sex- matched to participants, those aged 50 or over without known heart disease.
n=20
|
68Gallium FAPI PET/MR scan
|
|
Acute myocardial infarction - multi-timepoint imaging
Those aged 50 or over with recent myocardial infarction who will be imaged using PET/MR at 1,2,4, and 12 weeks post-MI.
n=20
|
68Gallium FAPI PET/MR scan
|
|
Acute or chronic myocardial infarction - single timepoint imaging
Those aged 50 or over with recent (n=20) or prior established (>24 months, n=20) myocardial infarction who will be imaged at a single timepoint (1,2,4, or 12 weeks post-MI for acute, at the time of enrolement to the study for chronic).
|
68Gallium FAPI PET/MR scan
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time of maximal fibrosis activity following myocardial infarction
Time Frame: 12 weeks
|
SUVmax and TBR of 68Ga-FAPI uptake within the infarct, border zone, and remote myocardium
|
12 weeks
|
|
Whether fibrosis activity predicts myocardial scar volume and ventricular remodelling
Time Frame: 12 months
|
As measured by CMR 12 months following acute MI
|
12 months
|
|
Fibrosis activity and myocardial remodelling within atherosclerotic plaque in patients with myocardial infarct
Time Frame: 12 weeks
|
SUVmax and TBR of 68Ga-FAPI uptake within areas of atherosclerotic plaque in the aorta and/or carotid arteries
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 21, 2021
Primary Completion (Actual)
December 31, 2023
Study Completion (Actual)
December 31, 2023
Study Registration Dates
First Submitted
April 26, 2022
First Submitted That Met QC Criteria
April 26, 2022
First Posted (Actual)
May 2, 2022
Study Record Updates
Last Update Posted (Actual)
May 17, 2024
Last Update Submitted That Met QC Criteria
May 16, 2024
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 262477
- E202251 (Other Identifier: University of Edinburgh)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.