Acute Myocardial Infarction (AMI)REMODEL-FAPINCT07684924
Early Ga-68 FAPI PET/MR After Acute Myocardial Infarction
An observational study of Acute Myocardial Infarction (AMI), run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
Acute myocardial infarction (AMI) initiates a complex myocardial repair process involving inflammation, fibroblast activation, and extracellular matrix remodeling, which may ultimately lead to adverse left ventricular remodeling and impaired cardiac function. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Acute Myocardial Infarction (AMI)
- What is being tested?
- 68Ga-FAPI-04 PET/MR
- How many people
- 25 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2026to 29 Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with acute myocardial infarction prospectively enrolled to undergo hybrid 68Ga-FAPI PET/MR imaging for assessment of myocardial fibroblast activation following infarction.
Who may be able to join
- Age ≥18 years.
- Diagnosis of acute myocardial infarction according to current guideline criteria.
- Successful coronary revascularization when clinically indicated.
- Ability to undergo FAPI PET/MR.
- Written informed consent.
Who cannot join
- Contraindications to MRI (e.g., non-MR-compatible implanted devices, severe claustrophobia).
- Pregnancy or breastfeeding.
- Severe renal impairment precluding gadolinium administration (if contrast-enhanced MR is performed).
- Inability to provide informed consent.
- Any condition considered by the investigator to interfere with study participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara University Faculty of Medicine, Department of Nuclear Medicine
Ankara, 06590
Elgin Ozkan, Prof. Dr., ozkanelgin@yahoo.com
About this study
Official title: Early Ga-68 FAPI PET/MR for Assessment of Left Ventricular Remodeling After Acute Myocardial Infarction: A Prospective Single-Center Observational Study
Acute myocardial infarction (AMI) initiates a complex myocardial repair process involving inflammation, fibroblast activation, and extracellular matrix remodeling, which may ultimately lead to adverse left ventricular remodeling and impaired cardiac function. Fibroblast activation protein (FAP)-targeted positron emission tomography (PET) enables noninvasive visualization of activated fibroblasts and may provide an early imaging biomarker of myocardial remodeling. This prospective single-center observational study aims to evaluate myocardial fibroblast activation using Ga-68 FAPI PET/MR performed approximately 10 ± 2 days after AMI and to investigate its association with subsequent left ventricular remodeling. Serial cardiac magnetic resonance (CMR) examinations will be performed at 3 and 6 months to assess changes in ventricular function and remodeling. The study will investigate whether early myocardial FAPI uptake is associated with subsequent structural and functional changes detected by CMR and evaluate the potential role of Ga-68 FAPI PET/MR as an imaging biomarker for post-infarction remodeling.
Read the detailed description
Acute myocardial infarction (AMI) initiates a dynamic myocardial repair process characterized by inflammation, fibroblast activation, extracellular matrix remodeling, and scar formation. Although these processes are essential for infarct healing, excessive or dysregulated remodeling may result in adverse left ventricular (LV) remodeling, progressive deterioration of cardiac function, and subsequent heart failure. Early identification of patients at risk for adverse remodeling remains an important unmet clinical need.
Fibroblast activation protein (FAP) is transiently expressed by activated fibroblasts during tissue repair and fibrosis. Ga-68 FAPI PET enables noninvasive visualization of fibroblast activation in vivo and has recently emerged as a promising molecular imaging technique for assessing myocardial remodeling following AMI. However, the relationship between early myocardial FAPI uptake and subsequent structural and functional cardiac remodeling has not been fully established.
This prospective, single-center observational study aims to evaluate myocardial fibroblast activation using integrated Ga-68 FAPI PET/MR performed approximately 10 ± 2 days after acute myocardial infarction. Participants will subsequently undergo serial cardiac magnetic resonance (CMR) examinations at 3 and 6 months to assess left ventricular remodeling, ventricular function, infarct characteristics, and myocardial fibrosis.
The primary objective is to investigate the association between early myocardial FAPI uptake and subsequent left ventricular remodeling assessed by serial CMR. Secondary objectives include evaluating the relationship between quantitative FAPI PET parameters and changes in left ventricular function, infarct characteristics, myocardial fibrosis, and relevant clinical and laboratory parameters. This study seeks to evaluate the potential value of Ga-68 FAPI PET/MR as an early imaging biomarker of post-infarction myocardial remodeling.
- Conditions
- Acute Myocardial Infarction (AMI)
- Being tested
- 68Ga-FAPI-04 PET/MR
- Keywords
- Ga-68 FAPI, FAPI PET/MR, Cardiac PET, Left Ventricular Remodeling, Cardiac Magnetic Resonance, Fibroblast Activation Protein
- Medical subject headings
- Ventricular Remodeling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-FAPI-04 PET/MRDiagnostic test
Hybrid 68Ga-FAPI PET/MR performed to evaluate myocardial fibroblast activation following acute myocardial infarction. PET and MR imaging findings will be analyzed in relation to infarct characteristics, myocardial function, and clinical outcomes.
| Study group | Role | What they receive |
|---|---|---|
| Acute Myocardial Infarction Patients | Patients with acute myocardial infarction who underwent FAPI PET/MR as part of the study protocol. Imaging findings will be analyzed in relation to infarct-related clinical, laboratory, and cardiac imaging parameters. Receives: Diagnostic Test: 68Ga-FAPI-04 PET/MR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left Ventricular Remodeling Assessed by Cardiac Magnetic Resonance Imaging
Association between early myocardial Ga-68 FAPI uptake and left ventricular remodeling assessed by serial cardiac magnetic resonance imaging using changes in left ventricular volumes and systolic function.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start1 Jul 2026
- Primary completion29 Jun 2028 (estimated)
- Study completion29 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial Infarction (AMI)Studies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- 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
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elgin Ozkan, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07684924
- Sponsor's protocol ID
- AU-İ01-48-26-FAPI-AMI
- Acronym
- REMODEL-FAPI
- Status last verified
- Jul 2026
- First submitted
- 28 Jun 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because of institutional policies and the need to protect participant confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Ga-68 FAPI PET/MR for Assessment of Left Ventricular Remodeling After Acute Myocardial Infarction: A Prospective Single-Center Observational Study
- ClinicalTrials.gov ID
- NCT07684924
- Acronym / sponsor ID
- REMODEL-FAPI / AU-İ01-48-26-FAPI-AMI
- Conditions
- Acute Myocardial Infarction (AMI)
- Keywords
- Ga-68 FAPI, FAPI PET/MR, Cardiac PET, Left Ventricular Remodeling, Cardiac Magnetic Resonance, Fibroblast Activation Protein
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 29 Jun 2028 (estimated)
- Study completion
- 29 Jun 2028 (estimated)
- First posted
- 6 Jul 2026 (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.
Acute myocardial infarction (AMI) initiates a complex myocardial repair process involving inflammation, fibroblast activation, and extracellular matrix remodeling, which may ultimately lead to adverse left ventricular remodeling and impaired cardiac function. Fibroblast activation protein (FAP)-targeted positron emission tomography (PET) enables noninvasive visualization of activated fibroblasts and may provide an early imaging biomarker of myocardial remodeling. This prospective single-center observational study aims to evaluate myocardial fibroblast activation using Ga-68 FAPI PET/MR performed approximately 10 ± 2 days after AMI and to investigate its association with subsequent left ventricular remodeling. Serial cardiac magnetic resonance (CMR) examinations will be performed at 3 and 6 months to assess changes in ventricular function and remodeling. The study will investigate whether early myocardial FAPI uptake is associated with subsequent structural and functional changes detected by CMR and evaluate the potential role of Ga-68 FAPI PET/MR as an imaging biomarker for post-infarction remodeling.
Detailed description
Acute myocardial infarction (AMI) initiates a dynamic myocardial repair process characterized by inflammation, fibroblast activation, extracellular matrix remodeling, and scar formation. Although these processes are essential for infarct healing, excessive or dysregulated remodeling may result in adverse left ventricular (LV) remodeling, progressive deterioration of cardiac function, and subsequent heart failure. Early identification of patients at risk for adverse remodeling remains an important unmet clinical need.
Fibroblast activation protein (FAP) is transiently expressed by activated fibroblasts during tissue repair and fibrosis. Ga-68 FAPI PET enables noninvasive visualization of fibroblast activation in vivo and has recently emerged as a promising molecular imaging technique for assessing myocardial remodeling following AMI. However, the relationship between early myocardial FAPI uptake and subsequent structural and functional cardiac remodeling has not been fully established.
This prospective, single-center observational study aims to evaluate myocardial fibroblast activation using integrated Ga-68 FAPI PET/MR performed approximately 10 ± 2 days after acute myocardial infarction. Participants will subsequently undergo serial cardiac magnetic resonance (CMR) examinations at 3 and 6 months to assess left ventricular remodeling, ventricular function, infarct characteristics, and myocardial fibrosis.
The primary objective is to investigate the association between early myocardial FAPI uptake and subsequent left ventricular remodeling assessed by serial CMR. Secondary objectives include evaluating the relationship between quantitative FAPI PET parameters and changes in left ventricular function, infarct characteristics, myocardial fibrosis, and relevant clinical and laboratory parameters. This study seeks to evaluate the potential value of Ga-68 FAPI PET/MR as an early imaging biomarker of post-infarction myocardial remodeling.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute Myocardial Infarction Patients | – | Diagnostic Test: 68Ga-FAPI-04 PET/MRPatients with acute myocardial infarction who underwent FAPI PET/MR as part of the study protocol. Imaging findings will be analyzed in relation to infarct-related clinical, laboratory, and cardiac imaging parameters. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with acute myocardial infarction prospectively enrolled to undergo hybrid 68Ga-FAPI PET/MR imaging for assessment of myocardial fibroblast activation following infarction.
Key inclusion criteria (5 listed)
- Age ≥18 years.
- Diagnosis of acute myocardial infarction according to current guideline criteria.
- Successful coronary revascularization when clinically indicated.
- Ability to undergo FAPI PET/MR.
- Written informed consent.
Key exclusion criteria (5 listed)
- Contraindications to MRI (e.g., non-MR-compatible implanted devices, severe claustrophobia).
- Pregnancy or breastfeeding.
- Severe renal impairment precluding gadolinium administration (if contrast-enhanced MR is performed).
- Inability to provide informed consent.
- Any condition considered by the investigator to interfere with study participation.
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 |
|---|---|---|
| 68Ga-FAPI-04 PET/MRHybrid 68Ga-FAPI PET/MR performed to evaluate myocardial fibroblast activation following acute myocardial infarction. PET and MR imaging findings will be analyzed in relation to infarct characteristics, myocardial function, and clinical outcomes. | Diagnostic test | Acute Myocardial Infarction Patients |
Primary outcome
Left Ventricular Remodeling Assessed by Cardiac Magnetic Resonance Imaging
Time frame: 6 months
Association between early myocardial Ga-68 FAPI uptake and left ventricular remodeling assessed by serial cardiac magnetic resonance imaging using changes in left ventricular volumes and systolic function.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because of institutional policies and the need to protect participant confidentiality.
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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.
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 Acute Myocardial Infarction (AMI), run by Ankara University at 1 site in Turkey (Türkiye).
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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 27 Jul 2026. 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elgin Ozkan, Prof.Dr. (+90 312 595 6445, ozkanelgin@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left Ventricular Remodeling Assessed by Cardiac Magnetic Resonance Imaging (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jul 2026.