ICI 재활에 대한 모니터링 및 재활: 코호트 연구
ICIAM의 한약 및 양약 특성 모니터링 및 재활 프로그램에 대한 연구: 코호트 연구
Immune checkpoint inhibitor-associated cardiac injury (ICIACI) is a low-incidence but highly fatal adverse event. A significant knowledge gap exists regarding the disease characteristics and recovery status of patients during the ICIACI convalescent phase. The objectives of this study are to establish a national, multicenter cohort for this patient population and to comprehensively describe their clinical profiles from an integrated Traditional Chinese and Western medicine standpoint, as well as their current rehabilitation status.
연구 개요
상태
상세 설명
The cohort study consists of a retrospective and a prospective cohort, enrolling eligible rehabilitation ICIACI patients from multiple centers across China. The retrospective cohort records baseline assessment data from electronic medical records and clinical sources, including demographics, cancer diagnosis and immunotherapy details, laboratory tests, electrocardiograms, imaging studies, quality of life and exercise tolerance assessments, TCM syndrome scores, and rehabilitation information, to define TCM and Western medicine clinical characteristics and rehabilitation status. The prospective cohort patients are followed up at 2, 4, and 12 weeks after enrollment, with MACE as the primary endpoint and quality of life scores as the secondary endpoint, to evaluate influencing factors of rehabilitation and its impact on prognosis.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Chengcheng Li, Dr
- 전화번호: 010-84206809
- 이메일: lcc77983@126.com
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
Under the established protocol, patients presenting with ICIACI will be enrolled from the China-Japan Friendship Hospital, Fuwai Hospital of the Chinese Academy of Medical Sciences, the Second Affiliated Hospital of Nanchang University, and Weifang Hospital of Traditional Chinese Medicine during the period from December 2025 to July 2028.
설명
Inclusion Criteria:
- Aged 18 to 80 years, inclusive
- Malignancy confirmed by cytology or histopathology
- Diagnosis of ICIACI following ICI therapy
- Assessed by the Multidisciplinary Team for Immune-Related Adverse Events as clinically recovered and entering the rehabilitation.
Exclusion Criteria:
- Diagnosis of fulminant myocarditis or cardiac function of NYHA IV
- Clear evidence suggesting cardiac injury not attributable to ICIs
- Concurrent acute cardiovascular events or malignant arrhythmias
- Coexisting severe immune-related adverse events affecting other organ systems
- Associated severe systemic diseases, such as severe hepatic or renal insufficiency, or severe infection.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: COHORT
- 시간 관점: OTHER
코호트 및 개입
그룹/코호트 |
|---|
|
ICIACI-Rehab Cohort
This observational cohort includes patients with immune checkpoint inhibitor-associated cardiac injury (ICIACI). Clinical characteristics, cardiac function, rehabilitation status, and clinical outcomes are assessed during follow-up. Rehabilitation and other treatments are provided according to routine clinical practice, without interventions assigned by the study protocol. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
MACE
기간: 2, 4, and 12 weeks after enrollment
|
Cardiovascular Death, Cardiac Arrest, Cardiogenic Shock, High-Grade Atrioventricular Block |
2, 4, and 12 weeks after enrollment
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Health Utility Index
기간: 2, 4, and 12 weeks after enrollment
|
The EQ-5D-5L assesses health-related quality of life across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Responses are converted into a health utility index using the Chinese EQ-5D-5L value set, with scores ranging from -0.391 to 1.000. Higher scores indicate better health-related quality of life. Changes from baseline to Weeks 2, 4, and 12 will be assessed. |
2, 4, and 12 weeks after enrollment
|
|
Change in EuroQol Visual Analogue Scale (EQ VAS) Score
기간: 2, 4, and 12 weeks after enrollment
|
The EuroQol Visual Analogue Scale (EQ VAS) assesses participants' self-rated overall health status on a scale ranging from 0 (worst imaginable health) to 100 (best imaginable health). Higher scores indicate better self-rated health. Changes from baseline to Weeks 2, 4, and 12 will be assessed. |
2, 4, and 12 weeks after enrollment
|
공동 작업자 및 조사자
협력자
수사관
- 수석 연구원: Jingyi Ren, Professor, China-Japan Friendship Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
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
기타 연구 ID 번호
- 2023ZD0502805-01
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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