Immune Checkpoint Therapy Clinical Trial
Official title:
STRICT - Surveillance With TRoponin During Immune Checkpoint Therapy
To learn if monitoring blood levels of heart injury (troponin levels) in cancer participants treated with immune checkpoint inhibitors will lead to decreased heart-related side effects.
Primary Objectives: - Myocarditis CTCAE version 5.0 grade ≥ 3 - Ventricular tachycardia (≥ 30 seconds) - Advanced atrioventricular block - Incident heart failure event - Cardiovascular mortality - Non-fatal sudden cardiac arrest - Acute coronary syndrome - Pericarditis - Pericardial tamponade Secondary Objectives: - Time from symptom onset to diagnosis of major adverse cardiovascular events - Time from symptom onset to diagnosis of myocarditis - Initial hospitalization duration for the adverse cardiovascular event from primary endpoint - Peak biomarker levels including troponin T, troponin I, creatine kinase, and creatine kinase myocardial band - Percentage of patients with negative workup for myocarditis - Percentage of patients requiring major cardiac testing including echocardiograms, cardiac magnetic resonance imaging, and/or invasive heart catheterization - Duration of interruption and/or discontinuation of immune checkpoint inhibitor therapy - Cancer progression free survival - Time to next cancer therapy ;