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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Immune Checkpoint Inhibitor-Related Myocarditis

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.

• Study Type: Observational
• Enrollment (Estimated): 340

Contacts and Locations

• Study Contact: Name: Chengcheng Li, Dr; Phone Number: 010-84206809; Email: lcc77983@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
ICIACI-Rehab Cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MACE	Cardiovascular Death, Cardiac Arrest, Cardiogenic Shock, High-Grade Atrioventricular Block	2, 4, and 12 weeks after enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EQ-5D	This study employed the EuroQol 5-Dimensions 5-Level questionnaire (EQ-5D-5L). It consists of two parts: Health Description System:Responses were converted to a single health utility index score using the Chinese value set (range: -0.391 to 1.000). A higher score indicates better health-related quality of life. Visual Analogue Scale (EQ-VAS): Patients rated their current overall health from 0 (worst imaginable) to 100 (best imaginable). A higher score reflects better self-rated health. Changes in both the index score and EQ-VAS score from before to after the intervention were compared.	2, 4, and 12 weeks after enrollment

Collaborators and Investigators

• Sponsor: China-Japan Friendship Hospital
• Collaborators: Chinese Academy of Medical Sciences, Fuwai Hospital; Second Affiliated Hospital of Nanchang University; Weifang Hospital of Traditional Chinese Medicine
• Investigators: Principal Investigator: Jingyi Ren, Professor, China-Japan Friendship Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): December 30, 2025
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2028

Study Registration Dates

• First Submitted: November 30, 2025
• First Submitted That Met QC Criteria: December 11, 2025
• First Posted (Actual): December 12, 2025

Study Record Updates

• Last Update Posted (Actual): December 12, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 2023ZD0502805-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No