PROFILE-MI - The FAPI Fibrosis Study

NCT05356923 | Completed

• 2 other identifiers: 262477E202251
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocardial Infarction; Myocardial Fibrosis

Outcome Measures

Primary Outcomes (3)

• 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

• Whether fibrosis activity predicts myocardial scar volume and ventricular remodelling

  As measured by CMR 12 months following acute MI

  12 months

• 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

Study Arms (3)

Healthy volunteers

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

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

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).

Radiation: 68Gallium FAPI PET/MR scan

Interventions

68Gallium FAPI PET/MR scan RADIATION

68Gallium FAPI PET/MR scan

Acute myocardial infarction - multi-timepoint imaging; Acute or chronic myocardial infarction - single timepoint imaging; Healthy volunteers

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• specific to cohort;
• aged 50 years or older

You may not qualify if:

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

Sponsors & Collaborators

• University of Edinburgh: lead

Study Sites (1)

Royal Infirmary of Edinburgh

Edinburgh, City Of Edinburgh, EH16 4SA, United Kingdom

Location

Related Publications (1)

• Barton AK, Craig NJ, Loganath K, Joshi S, Tsampasian V, Mahendran M, Lenell J, Tzolos E, Singh T, Whittington B, Nash J, Williams MC, van Beek EJR, MacAskill MG, Berkeley B, Vezaides S, Brittan M, Baker AH, Sellers S, Fletcher A, Clark T, Waight C, Slart RHJA, Berman D, Dey D, Slomka P, Newby DE, Dweck MR. Myocardial Fibroblast Activation After Acute Myocardial Infarction: A Positron Emission Tomography and Magnetic Resonance Study. J Am Coll Cardiol. 2025 Feb 18;85(6):578-591. doi: 10.1016/j.jacc.2024.10.103. Epub 2025 Jan 8.

  PMID: 39772364 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

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

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2022
• First Posted: May 2, 2022
• Study Start: April 21, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: May 17, 2024

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)