PROFILE-MI - The FAPI Fibrosis Study

Myocardial Infarction Clinical Trial

Official title:

PROline and FapI With Late Gadolinium Enhancement in Myocardial Infarction PROFILE-MI - The FAPI Fibrosis Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05356923
• Other study ID #: 262477
• Secondary ID: E202251
• Status: Completed
• Start date: April 21, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2023
• Source: University of Edinburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• specific to cohort;

• aged 50 years or older

Exclusion Criteria:

• Claustrophobia

• Inability to undergo MRI

• eGFR <30ml/min/1.73^m2

Related Conditions & MeSH terms

• Fibrosis
• Infarction
• Myocardial Fibrosis
• Myocardial Infarction

Intervention

Radiation:
• 68Gallium FAPI PET/MR scan
68Gallium FAPI PET/MR scan

Locations

Country	Name	City	State
United Kingdom	Royal Infirmary of Edinburgh	Edinburgh	City Of Edinburgh

Sponsors (1)

Lead Sponsor	Collaborator
University of Edinburgh

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time of maximal fibrosis activity following myocardial infarction	SUVmax and TBR of 68Ga-FAPI uptake within the infarct, border zone, and remote myocardium	12 weeks
Primary	Whether fibrosis activity predicts myocardial scar volume and ventricular remodelling	As measured by CMR 12 months following acute MI	12 months
Primary	Fibrosis activity and myocardial remodelling within atherosclerotic plaque in patients with myocardial infarct	SUVmax and TBR of 68Ga-FAPI uptake within areas of atherosclerotic plaque in the aorta and/or carotid arteries	12 weeks