Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05349058




Registration number
NCT05349058
Ethics application status
Date submitted
21/04/2022
Date registered
27/04/2022
Date last updated
27/04/2022

Titles & IDs
Public title
Assessment of Myocardial Injury in Patients Treated With Immune Checkpoint Inhibitors
Scientific title
Assessment of Myocardial Injury in Patients Treated With Immune Checkpoint Inhibitors
Secondary ID [1] 0 0
MIICI2022/1.3
Universal Trial Number (UTN)
Trial acronym
MIICI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myocarditis 0 0
Immune Checkpoint Inhibitors 0 0
Cardiotoxicity 0 0
Myocardial Injury 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Drugs - Immune Checkpoint Inhibitors

ICI patients - Patients receiving an Immune Checkpoint Inhibitor as treatment for their malignancy


Treatment: Drugs: Immune Checkpoint Inhibitors
Patients receive Immune Checkpoint Inhibitor as per oncology protocol
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Cardiac Troponin I (cTn I)
Timepoint [1] 0 0
6 weeks
Secondary outcome [1] 0 0
N-terminal prohormone brain natriuretic peptide (NT-ProBNP)
Timepoint [1] 0 0
6 weeks
Secondary outcome [2] 0 0
Global and regional left ventricular (LV) and right ventricular (RV) dysfunction
Timepoint [2] 0 0
6 weeks
Secondary outcome [3] 0 0
Major Adverse Cardiac Event (MACE)
Timepoint [3] 0 0
3 months
Secondary outcome [4] 0 0
Myocardial injury (CMR)
Timepoint [4] 0 0
6 weeks

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/01/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/12/2023
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Flinders Medical Centre - Adelaide
Recruitment postcode(s) [1] 0 0
5042 - Adelaide

Funding & Sponsors
Primary sponsor type
Other
Name
Flinders University
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
Flinders Medical Centre
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Government body
Name [2] 0 0
Lyell McEwin Hospital
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT05349058
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Joseph B Selvanyagam, Md, PhD
Address 0 0
Flinders Univeristy
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Joseph B Selvanyagam, MD, PhD
Address 0 0
Country 0 0
Phone 0 0
08 8177 1599
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05349058