Myocardial InfarctionNCT05356923
PROFILE-MI - The FAPI Fibrosis Study
An observational study of Myocardial Infarction and Myocardial Fibrosis, run by University of Edinburgh at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myocardial Infarction, Myocardial Fibrosis
- What is being tested?
- 68Gallium FAPI PET/MR scan
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 Apr 2021to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- specific to cohort;
- aged 50 years or older
Who cannot join
- Claustrophobia
- Inability to undergo MRI
- eGFR <30ml/min/1.73^m2
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Infirmary of Edinburgh
Edinburgh, City Of Edinburgh, EH16 4SA
About this study
Official title: 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.
Read the 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.
- Conditions
- Myocardial Infarction, Myocardial Fibrosis
- Being tested
- 68Gallium FAPI PET/MR scan
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Gallium FAPI PET/MR scanRadiation
68Gallium FAPI PET/MR scan
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Age- and sex- matched to participants, those aged 50 or over without known heart disease. n=20 Receives: 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 Receives: 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). Receives: Radiation: 68Gallium FAPI PET/MR scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of maximal fibrosis activity following myocardial infarction
SUVmax and TBR of 68Ga-FAPI uptake within the infarct, border zone, and remote myocardium
Measured: 12 weeks
Whether fibrosis activity predicts myocardial scar volume and ventricular remodelling
As measured by CMR 12 months following acute MI
Measured: 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
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start21 Apr 2021
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05356923
- Sponsor's protocol ID
- 262477
- Other IDs
- E202251
- Status last verified
- Mar 2023
- First submitted
- 26 Apr 2022
- Last updated
- 17 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39772364
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROline and FapI With Late Gadolinium Enhancement in Myocardial Infarction PROFILE-MI - The FAPI Fibrosis Study
- ClinicalTrials.gov ID
- NCT05356923
- Acronym / sponsor ID
- 262477
- Conditions
- Myocardial Infarction, Myocardial Fibrosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Study start
- 21 Apr 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 2 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | – | Radiation: 68Gallium FAPI PET/MR scanAge- and sex- matched to participants, those aged 50 or over without known heart disease. n=20 |
| Acute myocardial infarction - multi-timepoint imaging | – | Radiation: 68Gallium FAPI PET/MR scanThose 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 |
| Acute or chronic myocardial infarction - single timepoint imaging | – | Radiation: 68Gallium FAPI PET/MR scanThose 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). |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- specific to cohort;
- aged 50 years or older
Key exclusion criteria (3 listed)
- Claustrophobia
- Inability to undergo MRI
- eGFR <30ml/min/1.73^m2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 68Gallium FAPI PET/MR scan68Gallium FAPI PET/MR scan | Radiation | Acute myocardial infarction - multi-timepoint imaging, Acute or chronic myocardial infarction - single timepoint imaging, Healthy volunteers |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
- Derived from this study: PubMed 39772364Barton 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Infarction and Myocardial Fibrosis, run by University of Edinburgh at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time of maximal fibrosis activity following myocardial infarction (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05356923, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2024.