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Establishment of a Prediction Model and Grading Diagnostic Criteria for Immunotherapy-Related Cardiac Injury

Establishment of a Prediction Model and Grading Diagnostic Criteria for Immunotherapy-Related Cardiac Injury

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500095726
Enrollment
Unknown
Registered
2025-01-13
Start date
2025-01-15
Completion date
Unknown
Last updated
2025-01-27

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

Index test:Troponin T, electrocardiogram, echocardiogram, cardiac MRI

Sponsors

Zhongshan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Pathological diagnosis of malignant tumors; 2. Patients treated with immune checkpoint inhibitors for malignant tumors; 3. Complete drug treatment cycle and follow-up cycle; 4. 18 years old< = age< = 80 years; 5. Have not participated in other drug clinical studies within 1 month and voluntarily accept treatment under this regimen; 6. Termination Event: Cardiac Rehabilitation/Death.

Exclusion criteria

Exclusion criteria: 1. Patients with clear evidence that non-ICIs cause cardiac injury; 2. Serious adverse events other than cardiac side effects during the medication period, resulting in medication termination; 3. Patients with obvious cardiopulmonary, liver and kidney function impairment, accompanied by serious complications, such as coronary heart disease, cerebral infarction, COPD, etc.; 4. Expected survival < 6 months; 5. Data loss during follow-up.

Design outcomes

Primary

MeasureTime frame
cTNT;

Countries

China

Contacts

Public ContactCheng Leilei

Zhongshan Hospital, Fudan University

cheng.leilei@zs-hospital.sh.cn+86 13916866296

Outcome results

None listed

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