Assessment of Myocardial Injury in Patients Treated With Immune Checkpoint Inhibitors

NCT05349058 | Unknown

• 1 other identifier: MIICI2022/1.3
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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 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

Myocarditis; Immune Checkpoint Inhibitors; Cardiotoxicity; Myocardial Injury

Keywords

Immune Checkpoint Inhibtors (ICI); Cardiotoxicity

Outcome Measures

Primary Outcomes (1)

• Cardiac Troponin I (cTn I)

  Change in cTnI

  6 weeks

Secondary Outcomes (4)

• N-terminal prohormone brain natriuretic peptide (NT-ProBNP)

  6 weeks

• Global and regional left ventricular (LV) and right ventricular (RV) dysfunction

  6 weeks

• Major Adverse Cardiac Event (MACE)

  3 months

• Myocardial injury (CMR)

  6 weeks

Study Arms (1)

ICI patients

Patients receiving an Immune Checkpoint Inhibitor as treatment for their malignancy

Drug: Immune Checkpoint Inhibitors

Interventions

Immune Checkpoint Inhibitors DRUG

Patients receive Immune Checkpoint Inhibitor as per oncology protocol

ICI patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a asymptomatic cardiac status planned for treatment with Immune Checkpoint Inhibitor (ICI) (PD-1 and /or PD-L1) as apart of their protocol for malignancy.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Flinders University: lead
• Flinders Medical Centre: collaborator
• Lyell McEwin Hospital: collaborator

Study Sites (1)

Flinders Medical Centre

Adelaide, South Australia, 5042, Australia

RECRUITING

MeSH Terms

Conditions

Myocarditis; Cardiotoxicity

Interventions

Immune Checkpoint Inhibitors

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses

Study Officials

• Joseph B Selvanyagam, Md, PhD

  Flinders Univeristy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joseph B Selvanyagam, MD, PhD

CONTACT

08 8177 1599; j.selva@sa.gov.au

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Joseph Selvanayagam

Study Record Dates

• First Submitted: April 21, 2022
• First Posted: April 27, 2022
• Study Start: January 17, 2021
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: April 27, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)