A Study on the Clinical Classification and Outcome-Related Biological Markers of Immune Checkpoint Inhibitor-Related Myocarditis in Lung Cancer Patients

Status: Recruiting

Location: See location...

Intervention Type: Diagnostic test

Study Type: Observational

SUMMARY

This study aims to investigate the clinical classification and outcome-related biomarkers of immune checkpoint inhibitor (ICI)-related myocarditis in patients with lung cancer.A total of 50 patients with ICI-related myocarditis will be enrolled, including 25 with severe/critical myocarditis and 25 with subclinical/mild myocarditis. Blood samples will be collected at baseline and at follow-up time points (3 days, 7 days, and before discharge). Traditional myocardial injury markers, iron metabolism-related markers, and immunological markers will be measured and compared between groups. Changes in biomarkers after treatment will also be assessed. Clinical information such as in-hospital mortality and 3-month survival rates will be integrated to develop a severity assessment model. This model aims to evaluate disease severity and prognostic risk accurately by combining biomarkers, enhancing their application in clinical management.

Eligibility

Participation Requirements

Sex: All

Minimum Age: 18

Healthy Volunteers: f

View:

• Pathologically confirmed lung cancer and having received at least one dose of immune checkpoint inhibitor therapy;

• Clinically diagnosed with immune checkpoint inhibitor-related myocarditis;

• Aged 18 years or older;

• Voluntarily signed informed consent after being fully informed.

Locations

Other Locations

China

Shanghai Chest Hospital

RECRUITING

Shanghai

Contact Information

Primary

Yanbin Kuang, PhD

kybkyb2@163.com

+86 021-22200000

Time Frame

Start Date: 2025-01-30

Estimated Completion Date: 2028-12-30

Participants

Target number of participants: 50

Treatments

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 .

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.

Related Therapeutic Areas

Lung Cancer

Cardiomyopathy

Myocarditis

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A Study on the Clinical Classification and Outcome-Related Biological Markers of Immune Checkpoint Inhibitor-Related Myocarditis in Lung Cancer Patients

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