A prospective observational study of patients with advanced cancer for the evaluation of checkpoint inhibitor-associated cardiovascular immune-related adverse events
Not Applicable
- Conditions
- Advanced non-small-cell lung cancer and advanced gastric cancer which are indications for anti-cytotoxic T-lymphocyte-associated antigen-4, anti-programmed death-1, and anti-programmed death-ligand 1 antibodies.
- Registration Number
- JPRN-UMIN000032729
- Lead Sponsor
- Frontline Immunotherapy Team, Sendai Kousei Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 129
Inclusion Criteria
Not provided
Exclusion Criteria
Patients who undergo hemodialysis or have anaphylactic reactions to immune checkpoint inhibitors
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary outcomes: Subclinical or smoldering cardiac toxicity, defined as a composite of BNP elevation up to 200 pg/mL, positive troponin T, elevated CK-MB, new-onset morphological electrocardiogram abnormalities, or a reduction in the left ventricular ejection fraction of >10% compared to baseline.
- Secondary Outcome Measures
Name Time Method Secondary outcomes: (1) clinically apparent acute myocarditis; (2) acute heart failure, cardiogenic shock of unknown etiology, or symptomatic deterioration in at least one New York Heart Association functional class; (3) lethal arrhythmia, including advanced or complete AV block, ventricular tachycardia, or fibrillation; (4) cardiac death, new-onset acute coronary syndromes, any coronary revascularization procedure; (5) other immune-related adverse events, including dermatological, ophthalmological, neurological, hematological, gastrointestinal, endocrine, genitourinary, respiratory, and musculoskeletal adverse events; and (6) all-cause death.