STRICT - Surveillance With TRoponin During Immune Checkpoint Therapy
M.D. Anderson Cancer Center
Summary
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.
Description
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Male or female patient ≥18 years old * Plan for treatment with an immune checkpoint inhibitor as standard of care even if patient is also on an additional investigational cancer therapeutic * Willingness to provide informed consent Exclusion Criteria: * Troponin T not available at screening or prior to randomization * Inability to comply with planned study procedures * Major adverse cardiovascular event included in the primary outcome within the 30 days prior to enrollment * Any medical condition that could interfere with, or for which the treatment might interfere wit…
Interventions
- Diagnostic TestTroponin surveillance
Troponin will be monitored prior to each immune checkpoint inhibitor infusion for the first 12 weeks of therapy.
- OtherStandard of care
Standard of care if symptoms arise then evaluation with cardiac biomarkers and/or further cardiac testing.
Location
- MD Anderson Cancer CenterHouston, Texas