Immune Checkpoint Inhibitor-Related Myocarditis
Conditions
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.
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.
Interventions
None listed
Sponsors
Weifang Hospital of Traditional Chinese Medicine
Chinese Academy of Medical Sciences, Fuwai Hospital
Second Affiliated Hospital of Nanchang University
China-Japan Friendship Hospital
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MACE | 2, 4, and 12 weeks after enrollment | Cardiovascular Death, Cardiac Arrest, Cardiogenic Shock, High-Grade Atrioventricular Block |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| EQ-5D | 2, 4, and 12 weeks after enrollment | 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. |
Contacts
Primary ContactChengcheng Li, Dr
Outcome results
None listed