Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 12:22 AM
NCT ID:
NCT05349058
Eligibility Criteria:
Inclusion Criteria:
* Written informed consent will be obtained before any assessment is performed
* ≥ 18 years of age, male or female
* Patients planned for treatment with ICI (PD-1 and /or PD-L1) for malignancy
* Treatment naïve to ICI
* Asymptomatic cardiac status
* LVEF ≥55% by echocardiography during the screening period or within 6 months prior to study entry
Exclusion Criteria:
* Any prior echocardiographic measurement of LVEF \<55%
* Prior diagnosis and treatment for cardiac disease (myocardial infarction or angina, cardiomyopathy / heart failure, valvular heart disease)
* Elevated NT-proBNP \> 600 pg/ml (\> 900 pg/ml in the presence of atrial fibrillation).
* Life expectancy of less than 6 months
* Severe respiratory diseases requiring long-term oxygen therapy
* Patients enrolled in another clinical trial
* Pregnant and lactating women
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05349058
Study Brief:
Protocol Section:
NCT05349058