NCT06337097

STRICT - Surveillance With TRoponin During Immune Checkpoint Therapy

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 980 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 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

Conditions

• Immune Checkpoint Therapy

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Troponin surveillance	Troponin will be monitored prior to each immune checkpoint inhibitor infusion for the first 12 weeks of therapy.
OTHER	Standard of care	Standard of care if symptoms arise then evaluation with cardiac biomarkers and/or further cardiac testing.

Timeline

• Start date: 2024-02-02
• Primary completion: 2026-12-31
• Completion: 2028-12-31
• First posted: 2024-03-29
• Last updated: 2026-01-20

Locations

1 site across 1 country: United States