Status:
UNKNOWN
Assessment of Myocardial Injury in Patients Treated With Immune Checkpoint Inhibitors
Lead Sponsor:
Flinders University
Collaborating Sponsors:
Flinders Medical Centre
Lyell McEwin Hospital
Conditions:
Myocarditis
Immune Checkpoint Inhibitors
Eligibility:
All Genders
18+ years
Brief Summary
ICI's have become the first-line treatment for patients with various malignancies. Although case studies represent fulminant myocarditis, there is uncertainty in prevalence of subclinical myocardial i...
Detailed Description
There has been an increasing recognition of the relationship between immune surveillance and tumour proliferation over the last four decades. One of the most important therapeutic advances as a result...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 17 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 30 2023
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05349058
Start Date
January 17 2021
End Date
December 30 2023
Last Update
April 27 2022
Active Locations (1)
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1
Flinders Medical Centre
Adelaide, South Australia, Australia, 5042