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Assessment of Myocardial Injury in Patients Treated With Immune Checkpoint Inhibitors

NCT05349058 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2022-04-27

No results posted yet for this study

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 injury induced by ICI's.

In this prospective study, ICI treatment naïve patients with no significant prior cardiovascular history were enrolled. Primary outcome was the prevalence and severity of cardiac Troponin I (cTnI) at 6 weeks following ICI. Secondary outcomes were change in global longitudinal strain (GLS) and right ventricular free wall strain (RV FWS) measured by echocardiography, myocardial injury as assessed by cardiovascular magnetic resonance (CMR) and major adverse cardiac events (MACE). MACE defined as composite of cardiovascular mortality, heart failure, hemodynamically significant arrhythmias or heart block at 3 months.

Conditions

Interventions

DRUG

Immune Checkpoint Inhibitors

Patients receive Immune Checkpoint Inhibitor as per oncology protocol

Sponsors & Collaborators

  • Flinders Medical Centre

    collaborator OTHER_GOV

  • Lyell McEwin Hospital

    collaborator OTHER_GOV

  • Flinders University

    lead OTHER

Principal Investigators

  • Joseph B Selvanyagam, Md, PhD · Flinders Univeristy

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-17
Primary Completion
2023-12-30
Completion
2023-12-30

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05349058 on ClinicalTrials.gov