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NCT Number: NCT07684924

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

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ankara University Faculty of Medicine, Department of Nuclear Medicine

Ankara, 06590, Turkey (Türkiye)

Location status: Recruiting

Location contact

Elgin Ozkan, Prof. Dr.

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

68Ga-FAPI-04 PET/MR

Diagnostic 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.

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Elgin Ozkan, Prof.Dr.

CONTACT

[email protected]

+90 312 595 6445

Sponsors and collaborators

Lead sponsor

Ankara University

Other

Registry information

Official study title

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

Acronym: REMODEL-FAPI

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 6, 2026
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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