Monitoring and Rehabilitation for ICIACI Rehabilitation：A Cohort Study

N/ANot Yet RecruitingNCT07278817

China-Japan Friendship Hospital340 enrolled

Overview

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.

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

340

Conditions

Immune Checkpoint Inhibitor-Related Myocarditis

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

MACE

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

Time frame: 2, 4, and 12 weeks after enrollment

Secondary Outcomes

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.

Time frame: 2, 4, and 12 weeks after enrollment

Central Contacts

Chengcheng Li, Dr

CONTACT

010-84206809 lcc77983@126.com

Data from ClinicalTrials.gov

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