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This is a prospective, open label, single arm study. A total of 300 patients with primary non-small cell lung cancer treated with PD-1/PD-L1 immune checkpoint inhibitors(ICIs) are expected to included . All patients will follow up for at least 1 year. Patients with cardiac adverse reactions after PD-1/PD-L1 immune checkpoint inhibitor treatment at admission or during the subsequently follow-up period will randomly assigned a random number to each patient by computer random sequence. Patients with odd random number will treat with RASI(renin-angiotensin system inhibitors), and those with even random number will treat with ARNI(angiotensin-receptor-neprilysin inhibitor).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| observation group | A total of 300 patients are expected to include in this group. And the cardiac adverse reactions related to immune checkpoint inhibitor will be observed. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| renin-angiotensin system inhibitors or angiotensin-receptor-neprilysin inhibitor | Drug | Patients with odd random number will treat with RASI(renin-angiotensin system inhibitors), and those with even random number will treat with ARNI(angiotensin-receptor-neprilysin inhibitor) |
| Measure | Description | Time Frame |
|---|---|---|
| Major Adverse Cardiovascular Events | a) Primary Outcome is Major Adverse Cardiovascular Events(MACE)related to ICIs,includes: cardiovascular death, myocardial infarction(nonfatal), stroke(nonfatal), heart failure that caused readmission | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Common Terminology Criteria for Adverse Events (CTCAE) | Common Terminology Criteria for Adverse Events (CTCAE) related to ICIs, includes: arrhythmia, cardiogenic chest pain, valvular heart disease, cardiomyopathy, myocardial pericardial disease | 1 year |
| All cause of death |
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Inclusion Criteria:
Exclusion Criteria:
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A total of 300 patients with primary non-small cell lung cancer treated with PD-1/PD-L1 immune checkpoint inhibitors(ICIs) are expected to included. And then the basic information and the examination results will be collected.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yunhua Xu | Contact | 86-021-22200000 | yhxu@shchest.org |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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every reason that cause patient's death after ICIs treatment |
| 1 year |
| examination indexes | The examination indexes that related to myocardial damage | 1 year |