An observational study in Acute Myocardial Infarction (AMI), sponsored by Ankara University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-07-27.
Sponsored by Ankara University · Observational
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.
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.
105 studies on the registry are indexed under Ventricular Remodeling; 24 are open to participants now.
This study's planned enrollment of 25 is below the median of 180 across 32 observational studies indexed under Ventricular Remodeling.
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Adult patients with acute myocardial infarction prospectively enrolled to undergo hybrid 68Ga-FAPI PET/MR imaging for assessment of myocardial fibroblast activation following infarction.
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Exclusion Criteria:
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Diagnostic Test: 68Ga-FAPI-04 PET/MR
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.
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.
Time frame: 6 months
Plan to share: No — Individual participant data will not be shared because of institutional policies and the need to protect participant confidentiality.
No publications or documents are linked to this record.
Started Jul 2026 (actual). Primary completion is estimated for Jun 2028, 23 months after the start.
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