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
Qualifiers
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 design
Treatments tested in this trial
- Not listed
Trial groups
340 Participants
are grouped into 1 trial groupLocations
Sponsors and collaborators
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