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 2026to 31 Jul 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 | This observational cohort includes patients with immune checkpoint inhibitor-associated cardiac injury (ICIACI). Clinical characteristics, cardiac function, rehabilitation status, and clinical outcomes are assessed during follow-up. Rehabilitation and other treatments are provided according to routine clinical practice, without interventions assigned by the study protocol. |
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 (2)
Change in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Health Utility Index
The EQ-5D-5L assesses health-related quality of life across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Responses are converted into a health utility index using the Chinese EQ-5D-5L value set, with scores ranging from -0.391 to 1.000. Higher scores indicate better health-related quality of life. Changes from baseline to Weeks 2, 4, and 12 will be assessed.
Measured: 2, 4, and 12 weeks after enrollment
Change in EuroQol Visual Analogue Scale (EQ VAS) Score
The EuroQol Visual Analogue Scale (EQ VAS) assesses participants' self-rated overall health status on a scale ranging from 0 (worst imaginable health) to 100 (best imaginable health). Higher scores indicate better self-rated health. Changes from baseline to Weeks 2, 4, and 12 will be assessed.
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 2026 (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.
- More trials run by China-Japan Friendship HospitalThe sponsor's other registered studies.
- 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
- Nov 2026
- First submitted
- 30 Nov 2025
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Monitoring of Traditional Chinese and Western Medicine Characteristics and Rehabilitation Program for ICIAM：A Cohort Study
- ClinicalTrials.gov ID
- NCT07278817
- Acronym / sponsor ID
- 2023ZD0502805-01
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 340 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Collaborators
- Weifang Hospital of Traditional Chinese Medicine, Chinese Academy of Medical Sciences, Fuwai Hospital, Second Affiliated Hospital of Nanchang University
- Study start
- 30 Dec 2026 (estimated)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 12 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICIACI-Rehab Cohort | – | –This observational cohort includes patients with immune checkpoint inhibitor-associated cardiac injury (ICIACI). Clinical characteristics, cardiac function, rehabilitation status, and clinical outcomes are assessed during follow-up. Rehabilitation and other treatments are provided according to routine clinical practice, without interventions assigned by the study protocol. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
MACE
Time frame: 2, 4, and 12 weeks after enrollment
Cardiovascular Death, Cardiac Arrest, Cardiogenic Shock, High-Grade Atrioventricular Block
2 secondary outcomes
Change in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Health Utility Index
Time frame: 2, 4, and 12 weeks after enrollment
Change in EuroQol Visual Analogue Scale (EQ VAS) Score
Time frame: 2, 4, and 12 weeks after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: No
Related trials for Immune Checkpoint Inhibitor-Related Myocarditis
Recruiting
Baduanjin Rehabilitation for Functional Restoration in ICI-Associated Myocarditis
Immune Checkpoint Inhibitors Related Myocarditis
Not yet recruitingObservational study
Cardiac Biomarkers in Patients Receiving Immune Checkpoint Inhibitors (PRIME-ICI)
Cardiotoxicity, Cardiac Biomarkers
RecruitingPhase 3
Abatacept in Immune Checkpoint Inhibitor Myocarditis
Myocarditis Acute, Cancer
RecruitingObservational study
AI-powered ECG Analysis for Deadly Arrhythmias and ICI Myocarditis
Arrhythmia, Long QT Syndrome
RecruitingObservational study
ATROPOS: Survival Analysis of ICI-associated Myocarditis
Immune Checkpoint Inhibitor-associated Myocarditis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jingyi Ren, Professor principal investigator
China-Japan Friendship Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Immune Checkpoint Inhibitor-Related Myocarditis, run by China-Japan Friendship Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chengcheng Li, Dr (010-84206809, lcc77983@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MACE (time frame: 2, 4, and 12 weeks after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.