Cardiovascular adverse events in lung cancer patients receiving immune checkpoint inhibitor therapy: An analysis of a nationwide electronic medical record data

Cardiovascular adverse events in lung cancer patients receiving immune checkpoint inhibitor therapy: An analysis of a nationwide electronic medical record data - CARE in ICI therapy

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000051698

Enrollment

2000

Registered

2023-08-30

Start date

2023-07-24

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

Patients with primary lung cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with primary lung cancer

Exclusion criteria

Exclusion criteria: 1) Patients with previous diagnosis of the following diseases are excluded from the analysis: Multiple myeloma BCR-ABL-positive chronic myelogenous leukemia Cervical cancer Ovarian cancer Hepatocellular carcinoma Gastric cancer Rectal cancer Colon cancer 3)Patients without a 180-day look-back period commencing at the time of first ICI treatment (study group) or at the time of the first start of predefined chemotherapy other than ICI (control group).

Design outcomes

Primary

Measure	Time frame
The following outcomes that occur within 180 days after the index date. 1. Any myocarditis 2. Severe myocarditis, including fulminant form of myocarditis 3. Acute myocardial infarction, unstable angina pectoris, and spastic angina pectoris 4. Symptomatic arrhythmias 5. Pericarditis 6. Sudden death and acute cardiac death 7. Acute heart failure requiring hospital admission 8. Deep vein thrombosis 9. Takotsubo cardiomyopathy Index date is defined as the time of the first ICI treatment (study group) or the time of the first start of predefined chemotherapy other than ICI (control group).	—

Measure

Time frame

The following outcomes that occur within 180 days after the index date. 1. Any myocarditis 2. Severe myocarditis, including fulminant form of myocarditis 3. Acute myocardial infarction, unstable angina pectoris, and spastic angina pectoris 4. Symptomatic arrhythmias 5. Pericarditis 6. Sudden death and acute cardiac death 7. Acute heart failure requiring hospital admission 8. Deep vein thrombosis 9. Takotsubo cardiomyopathy Index date is defined as the time of the first ICI treatment (study group) or the time of the first start of predefined chemotherapy other than ICI (control group).

—

Secondary

Measure	Time frame
The following outcomes that occur within 180 days after the index date. 1. Myasthenia gravis 2. Myositis 3. Polymyalgia rheumatica, 4. Hyperthyroidism/Hypothyroidism	—

Countries

Japan

Contacts

Public ContactTsuyoshi Isawa

Sendai Kousei Hospital Cardiology Department

isa_tsuyo@yahoo.co.jp+81222226181

Outcome results