Immune Checkpoint Inhibitor-Related MyocarditisNCT07278817
Monitoring and Rehabilitation for ICIACI Rehabilitation：A Cohort Study
An observational study of Immune Checkpoint Inhibitor-Related Myocarditis, run by China-Japan Friendship Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Immune Checkpoint Inhibitor-Related Myocarditis
- How many people
- 340 participants
- Where
- No sites listed yet
- Study dates
- 30 Dec 2025to 31 Jul 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ICIACI-Rehab Cohort | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
MACE
Cardiovascular Death, Cardiac Arrest, Cardiogenic Shock, High-Grade Atrioventricular Block
Measured: 2, 4, and 12 weeks after enrollment
Secondary 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.
Measured: 2, 4, and 12 weeks after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start30 Dec 2025 (estimated)
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune Checkpoint Inhibitor-Related MyocarditisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 340 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Weifang Hospital of Traditional Chinese Medicine, Chinese Academy of Medical Sciences, Fuwai Hospital, Second Affiliated Hospital of Nanchang University
- Responsible party
- Principal investigator, Jingyi Ren, China-Japan Friendship Hospital
- Investigators
- Jingyi Ren, Professor, Principal investigator, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07278817
- Sponsor's protocol ID
- 2023ZD0502805-01
- Status last verified
- Dec 2025
- First submitted
- 30 Nov 2025
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No