- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07684924
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
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Elgin Ozkan, Prof.Dr.
- 전화번호: +90 312 595 6445
- 이메일: ozkanelgin@yahoo.com
연구 장소
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Ankara, 터키 (Türkiye), 06590
- 모병
- Ankara University Faculty of Medicine, Department of Nuclear Medicine
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연락하다:
- Elgin Ozkan, Prof. Dr.
- 이메일: ozkanelgin@yahoo.com
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
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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.
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Left Ventricular Remodeling Assessed by Cardiac Magnetic Resonance Imaging
기간: 6 months
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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.
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6 months
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- AU-İ01-48-26-FAPI-AMI
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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