Study on the Monitoring of Traditional Chinese and Western Medicine Characteristics and Rehabilitation Program for ICIAM：A Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 340
- 主要终点
- MACE
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
MACE
时间窗: 2, 4, and 12 weeks after enrollment
Cardiovascular Death, Cardiac Arrest, Cardiogenic Shock, High-Grade Atrioventricular Block
次要结局
- EQ-5D(2, 4, and 12 weeks after enrollment)
研究者
Jingyi Ren
Professor of medicine(Cardiology), Deputy Director of the Cardiology Department and Director of the Heart Failure Center
China-Japan Friendship Hospital