A prospective observational study of patients with advanced cancer for the evaluation of checkpoint inhibitor-associated cardiovascular immune-related adverse events

A prospective observational study of patients with advanced cancer for the evaluation of checkpoint inhibitor-associated cardiovascular immune-related adverse events - AWARENESS-irAE registry

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000032729

Enrollment

200

Registered

2018-05-26

Start date

2018-05-16

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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.

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with 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.

Exclusion criteria

Exclusion criteria: Patients who undergo hemodialysis or have anaphylactic reactions to immune checkpoint inhibitors

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Japan

Contacts

Public ContactTsuyoshi Isawa

Sendai Kousei Hospital Cardiology

isa_tsuyo@yahoo.co.jp022-222-6181

Outcome results