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

NCT07684924 | Recruiting

• 1 other identifier: AU-İ01-48-26-FAPI-AMI
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Myocardial Infarction (AMI)

Keywords

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

Outcome Measures

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.

  6 months

Study Arms (1)

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.

Diagnostic Test: 68Ga-FAPI-04 PET/MR

Interventions

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.

Acute Myocardial Infarction Patients

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ankara University: lead

Study Sites (1)

Ankara University Faculty of Medicine, Department of Nuclear Medicine

Ankara, 06590, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Ventricular Remodeling

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Elgin Ozkan, Prof.Dr.

CONTACT

+90 312 595 6445; ozkanelgin@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.Dr.

Study Record Dates

• First Submitted: June 28, 2026
• First Posted: July 6, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): June 29, 2028
• Study Completion (Estimated): June 29, 2028
• Last Updated: July 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)