PROFILE-MI - The FAPI Fibrosis Study

• ClinicalTrials.gov Identifier: NCT05356923
• Recruitment Status: Active, not recruiting
• First Posted: May 2, 2022
• Last Update Posted: March 28, 2023
• Sponsor: University of Edinburgh
• Information provided by (Responsible Party): University of Edinburgh

Tracking Information

• First Submitted Date: April 26, 2022
• First Posted Date: May 2, 2022
• Last Update Posted Date: March 28, 2023
• Actual Study Start Date: April 21, 2021
• Estimated Primary Completion Date: October 11, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 26, 2022)

• 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
• Whether fibrosis activity predicts myocardial scar volume and ventricular remodelling [ Time Frame: 12 months ]
  As measured by CMR 12 months following acute MI
• 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

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: PROFILE-MI - The FAPI Fibrosis Study
• Official Title: PROline and FapI With Late Gadolinium Enhancement in Myocardial Infarction PROFILE-MI - The FAPI Fibrosis Study
• Brief 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.
• 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
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided

Biospecimen

Retention:   Samples Without DNA

Description:

Blood draw for all participants with recent or prior established myocardial infarction at each attendance for PET/MR scanning

• 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

Condition

• Myocardial Infarction
• Myocardial Fibrosis

Intervention

Radiation: 68Gallium FAPI PET/MR scan

68Gallium FAPI PET/MR scan

Study Groups/Cohorts

• Healthy volunteers
  Age- and sex- matched to participants, those aged 50 or over without known heart disease. n=20
  Intervention: Radiation: 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
  Intervention: Radiation: 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).
  Intervention: Radiation: 68Gallium FAPI PET/MR scan

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: April 26, 2022): 80
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: April 1, 2024
• Estimated Primary Completion Date: October 11, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• specific to cohort;
• aged 50 years or older

Exclusion Criteria:

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 50 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT05356923
• Other Study ID Numbers: 262477; E202251 ( Other Identifier: University of Edinburgh )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: University of Edinburgh
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Edinburgh
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: University of Edinburgh
• Verification Date: March 2023