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Early Ga-68 FAPI PET/MR After Acute Myocardial Infarction

Early Ga-68 FAPI PET/MR for Assessment of Left Ventricular Remodeling After Acute Myocardial Infarction: A Prospective Single-Center Observational Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07684924
Acronym
REMODEL-FAPI
Enrollment
25
Registered
2026-07-06
Start date
2026-07-01
Completion date
2028-06-29
Last updated
2026-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myocardial Infarction (AMI)

Keywords

Ga-68 FAPI, FAPI PET/MR, Cardiac PET, Left Ventricular Remodeling, Cardiac Magnetic Resonance, Fibroblast Activation Protein

Brief 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. 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.

Interventions

DIAGNOSTIC_TEST68Ga-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.

Sponsors

Ankara University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Left Ventricular Remodeling Assessed by Cardiac Magnetic Resonance Imaging6 monthsAssociation 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.

Countries

Turkey (Türkiye)

Contacts

CONTACTElgin Ozkan, Prof.Dr.
ozkanelgin@yahoo.com+90 312 595 6445

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 28, 2026