Monitoring and Rehabilitation for ICIACI Rehabilitation：A Cohort Study

China-Japan Friendship Hospital

Status: Not yet enrolling

Conditions: Immune Checkpoint Inhibitor-Related Myocarditis

Study type: Observational

Funder types: Other

Identifiers

NCT07278817

2023ZD0502805-01

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 340 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

340 participants in 1 patient group

ICIACI-Rehab Cohort