Monitoring and Rehabilitation for ICIACI Rehabilitation：A Cohort Study
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorChina-Japan Friendship Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
340 Participants
are grouped into 1 trial groupGroup A: ICIACI-Rehab Cohort
Trial outcomes
Primary outcomes
1
MACE
Cardiovascular Death, Cardiac Arrest, Cardiogenic Shock, High-Grade Atrioventricular Block
Time frame
2, 4, and 12 weeks after enrollmentSecondary outcomes
1
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 enrollmentLocations
Sponsors and contacts
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China-Japan Friendship Hospital
Lead sponsor
Weifang Hospital of Traditional Chinese Medicine
Collaborator
Chinese Academy of Medical Sciences, Fuwai Hospital
Collaborator
Second Affiliated Hospital of Nanchang University
Collaborator
Source ClinicalTrials.gov
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