PROFILE-MI - The FAPI Fibrosis Study

University of Edinburgh

Status: Completed

Conditions: Myocardial Fibrosis; Myocardial Infarction

Treatments: Radiation: 68Gallium FAPI PET/MR scan

Study type: Observational

Funder types: Other

Identifiers

NCT05356923

E202251 (Other Identifier)

262477

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• specific to cohort;
• aged 50 years or older

Exclusion criteria

• Claustrophobia
• Inability to undergo MRI
• eGFR <30ml/min/1.73^m2

Trial design

80 participants in 3 patient groups

Healthy volunteers

Description:

Age- and sex- matched to participants, those aged 50 or over without known heart disease. n=20

Treatment:

Radiation: 68Gallium FAPI PET/MR scan

Acute myocardial infarction - multi-timepoint imaging

Description:

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

Treatment:

Radiation: 68Gallium FAPI PET/MR scan

Acute or chronic myocardial infarction - single timepoint imaging

Description:

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).

Treatment:

Radiation: 68Gallium FAPI PET/MR scan