Early Ga-68 FAPI PET/MR After Acute Myocardial Infarction (REMODEL-FAPI)
Early Ga-68 FAPI PET/MR for Assessment of Left Ventricular Remodeling After Acute Myocardial Infarction: A Prospective Single-Center Observational Study
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Elgin Ozkan, Prof.Dr.
- Telefonnummer: +90 312 595 6445
- E-mail: ozkanelgin@yahoo.com
Studiesteder
-
-
-
Ankara, Tyrkiet (Türkiye), 06590
- Rekruttering
- Ankara University Faculty of Medicine, Department of Nuclear Medicine
-
Kontakt:
- Elgin Ozkan, Prof. Dr.
- E-mail: ozkanelgin@yahoo.com
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
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.
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Left Ventricular Remodeling Assessed by Cardiac Magnetic Resonance Imaging
Tidsramme: 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.
|
6 months
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- AU-İ01-48-26-FAPI-AMI
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .