Monitoring and Rehabilitation for ICIACI Rehabilitation：A Cohort Study

NCT07278817 | Not Yet Recruiting DMC

• 1 other identifier: 2023ZD0502805-01
• Study Type: observational
• Target: 340
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Immune Checkpoint Inhibitor-Related Myocarditis

Outcome Measures

Primary Outcomes (1)

• MACE

  Cardiovascular Death, Cardiac Arrest, Cardiogenic Shock, High-Grade Atrioventricular Block

  2, 4, and 12 weeks after enrollment

Secondary Outcomes (1)

• EQ-5D

  2, 4, and 12 weeks after enrollment

Study Arms (1)

ICIACI-Rehab Cohort

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• China-Japan Friendship Hospital: lead
• Weifang Hospital of Traditional Chinese Medicine: collaborator
• Chinese Academy of Medical Sciences, Fuwai Hospital: collaborator
• Second Affiliated Hospital of Nanchang University: collaborator

Study Officials

• Jingyi Ren, Professor

  China-Japan Friendship Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chengcheng Li, Dr

CONTACT

010-84206809; lcc77983@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of medicine(Cardiology), Deputy Director of the Cardiology Department and Director of the Heart Failure Center

Study Record Dates

• First Submitted: November 30, 2025
• First Posted: December 12, 2025
• Study Start: December 30, 2025
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share