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A multi-omics analysis and comparison of immune checkpoint inhibitor-associated myocarditis

A multi-omics analysis and comparison of immune checkpoint inhibitor-associated myocarditis

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500112764
Enrollment
Unknown
Registered
2025-11-19
Start date
2025-12-01
Completion date
Unknown
Last updated
2025-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immune Checkpoint Inhibitor-Associated Myocarditis

Interventions

Immune Checkpoint Inhibitor-Associated Myocarditis Research Group:None
Immune Checkpoint Inhibitor Non-myocarditis Research Group:None

Sponsors

The First Affiliated Hospital of Zhengzhou University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: The diagnosis of myocarditis is based on the diagnostic criteria proposed by Bonaca et al., (1) Histopathological features suggestive of myocarditis on endomyocardial biopsy or autopsy; (2) Cardiac magnetic resonance imaging diagnosis of myocarditis concurrent with clinical manifestations of myocarditis and elevated biomarkers or electrocardiographic evidence; (3) Echocardiography demonstrating new-onset wall motion abnormalities concurrent with clinical manifestations of myocarditis, elevated biomarkers, electrocardiographic evidence, and negative coronary angiography. Diagnostic criteria for ICI-associated myocarditis encompass meeting the aforementioned myocarditis diagnostic criteria in cancer patients receiving standard PD-1/PD-L1 therapy, with grading according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.

Exclusion criteria

Exclusion criteria: 1. Severe hepatic or renal impairment, coagulation disorders 2. Hyperthyroidism, anaemia, or any other severe cardiovascular or cerebrovascular disease 3. Malignant neoplasms 4. Severe infectious or contagious diseases 5. Autoimmune disorders 6. Age < 18 years 7. Patients with incomplete clinical records

Design outcomes

Primary

MeasureTime frame
Transcriptome;Metabolome;Proteome;

Countries

China

Contacts

Public ContactJunnan Tang

The First Affiliated Hospital of Zhengzhou University

fcctangjn@zzu.edu.cn+86 158 9069 5166

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026