Immune checkpoint inhibitor-associated myocarditis
Conditions
Interventions
MACE/non-MACE group:None
Sponsors
Department of Cardiovascular Medicine, Shanghai 10th People's Hospital Affiliated to Tongji University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) Age >18 years old; (2) Confirmed myocarditis, the patient must be clearly diagnosed as myocarditis by a clinician, which can be diagnosed by clinical manifestations, electrocardiogram, myocardial enzyme indicators, cardiac ultrasound, etc.; (3) Receiving immune checkpoint inhibitors (ICI) : Patients must be treated with ICI, either as a single drug or in combination with other drugs; (4) Be able to understand the purpose of the research, voluntarily participate in the research and sign the informed consent
Exclusion criteria
Exclusion criteria: (1) have other known heart diseases, such as coronary heart disease, cardiomyopathy, etc.; (2) have other known causes of heart disease, such as infectious myocarditis, drug-related myocarditis, etc.; (3) have received a heart transplant or instrumental assisted treatment; (4) Severe cardiac insufficiency, NYHA grade III-IV; (5) Pregnant or lactating women; (6) Suffering from serious systemic diseases, such as advanced cancer, renal failure, etc., affecting the survival prognosis; (7) There are contraindications to myocardial biopsy; (8) Have severe cognitive or communication difficulties, unable to cooperate with research requirements; (9) The subject has participated or is participating in a clinical trial of any other device or drug within the last 3 months; (10) The investigator considers that the subjects have other conditions that are not suitable for clinical trials
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| One year of all-cause death; | — |
Secondary
| Measure | Time frame |
|---|---|
| MACE;Myocardial biopsy; | — |
Countries
China
Contacts
Public ContactWenliang Che
Department of Cardiovascular Medicine, Shanghai 10th People's Hospital Affiliated to Tongji University
Outcome results
None listed