Biomarkers for Clinical Classification and Outcomes of Immune Checkpoint Inhibitor-Related-Related Myocarditis in Lung Cancer
NCT ID: NCT06818149
Last Updated: 2025-02-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
50 participants
OBSERVATIONAL
2025-01-30
2028-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Severe/critical group
Severe Type:
Significant symptoms (e.g., fatigue, palpitations, chest pain) triggered by daily activities without hemodynamic changes; elevated myocardial biomarkers (Cardiac troponin, creatine kinase, Creatine kinase myocardial band, Aspartate aminotransferase，natriuretic peptides); new ECG changes; structural and functional myocardial abnormalities on echocardiography or MRI.
Critical Type:
Intolerable symptoms (e.g., respiratory dysfunction, heart failure, cardiogenic shock) at rest or minimal activity, with hemodynamic instability; significantly elevated myocardial biomarkers (Cardiac troponin, creatine kinase, Creatine kinase myocardial band, Aspartate aminotransferase, natriuretic peptides); severe myocardial structural and functional abnormalities on echocardiography or MRI; new severe arrhythmias on ECG .
Biomarker Analysis for Severity Assessment
Blood samples will be collected at baseline and at follow-up time points (3 days, 7 days, and before discharge). Traditional myocardial injury biomarkers, iron metabolism-related biomarkers, and immunological biomarkers will be tested.
Subclinical myocardial injury/mild group
Subclinical Myocardial Injury: All three of the following criteria must be met:
1. No clinical symptoms triggered by daily activities;
2. Only mild elevation of Cardiac troponin levels without elevation of other myocardial injury biomarkers;
3. No abnormalities detected in other auxiliary examinations.
Mild Type: The following conditions must be met for diagnosis:
1. Daily activities may cause mild, nonspecific symptoms such as fatigue or shortness of breath;
2. Mild elevation of myocardial injury biomarkers (Cardiac troponin, creatine kinase, Creatine kinase myocardial band, Aspartate aminotransferase，natriuretic peptides);
3. Mild abnormalities on ECG, including new-onset sinus tachycardia, atrial arrhythmias, or nonspecific ST-T changes;
4. No structural or functional abnormalities of the myocardium detected by echocardiography or cardiac MRI.
Biomarker Analysis for Severity Assessment
Blood samples will be collected at baseline and at follow-up time points (3 days, 7 days, and before discharge). Traditional myocardial injury biomarkers, iron metabolism-related biomarkers, and immunological biomarkers will be tested.
Interventions
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Biomarker Analysis for Severity Assessment
Blood samples will be collected at baseline and at follow-up time points (3 days, 7 days, and before discharge). Traditional myocardial injury biomarkers, iron metabolism-related biomarkers, and immunological biomarkers will be tested.
Eligibility Criteria
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Inclusion Criteria
* Clinically diagnosed with immune checkpoint inhibitor-related myocarditis;
* Aged 18 years or older;
* Voluntarily signed informed consent after being fully informed.
Exclusion Criteria
* Presence of severe underlying cardiovascular diseases or recent acute cardiac events (e.g., myocardial infarction, severe arrhythmia);
* Concurrent other malignancies, immunosuppressive diseases, or autoimmune diseases;
* Inability to complete the required examinations and follow-ups specified in the study.
18 Years
ALL
No
Sponsors
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Shanghai Chest Hospital
OTHER
Responsible Party
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Yanbin Kuang
Attending Physician,PhD
Locations
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Shanghai Chest Hospital
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IS24178
Identifier Type: -
Identifier Source: org_study_id
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