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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorAnkara University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: Acute Myocardial Infarction Patients1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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