NCT07278817

Monitoring and Rehabilitation for ICIACI Rehabilitation：A Cohort Study

Study on the Monitoring of Traditional Chinese and Western Medicine Characteristics and Rehabilitation Program for ICIAM：A Cohort Study

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 340 (estimated)
• Sponsor: China-Japan Friendship Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Immune Checkpoint Inhibitor-Related Myocarditis

Timeline

• Start date: 2025-12-30
• Primary completion: 2028-07-31
• Completion: 2028-07-31
• First posted: 2025-12-12
• Last updated: 2025-12-12