Cardiac Magnetic Resonance Monitoring of Immune Checkpoint Inhibitor-related Cardiotoxicity

ConditionImmune Checkpoint Inhibitors, Cardiotoxicity

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexFemale

Age18-75

SponsorWest China Second University Hospital

About this trial

This study is a prospective cohort clinical research that analyzes the changes in CMR parameters before and after immune checkpoint inhibitors (ICIs) therapy in patients with gynecologic malignancies. It also evaluates the value of CMR parameters in predicting long-term outcomes. The baseline assessment will be conducted prior to ICIs treatment, followed by multiple assessments during the medication process including within one week prior to cycle 3 , within the week prior to cycle 5 , 1 year after the first dose, and 2 years after the first dose. Assessment will also be conducted after discontinuation of ICIs medication. The assessment includes clinical assessment, CMR imaging, echocardiography, serum cardiac injury biomarkers, etc. Cancer therapy-related cardiac dysfunction (CTRCD), survival, and major adverse cardiac events (MACE) will be followed up.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1. Female patients aged 18 to 75 years, diagnosed with gynecological malignancies through histology or cytology.

2. Patients who are preparing for monotherapy or combination therapy with ICIs.

3. Voluntary signing of informed consent form.

4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Disqualifiers

1. Previously received ICIs treatment.

2. With allergies or contraindications to ICIs.

3. Confirmed to be brain metastasis.

4. Patients who have major surgery within 4 weeks prior to or following the screening period.

Trial population

Patients with gynecologic malignancies who are preparing for ICIs treatment

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Cardiac magnetic resonance
Diagnostic test
Cardiac magnetic resonance protocols include cine, non-contrast T1-mapping and T2-mapping.

Treatment groups

22 Participants

are divided into 1 treatment group

Group A: Patients with gynecologic malignancies who are preparing for ICIs treatment1 intervention

Trial outcomes

Primary outcomes

cancer therapy-related cardiac dysfunction (CTRCD)

Any reduction of LVEF to below 50% or a \>10% reduction from baseline falling below the lower limit of normal.

Time frame

2 month to 3 years

Secondary outcomes

All-cause death; major adverse cardiac events (MACE)

MACE were defined as a composite of cardiovascular death, cardiac arrest,cardiogenic shock, myocarditis, acute coronary syndromes (including non-ST-segment elevation and ST-segment elevation myocardial infarction), congestive heart failure, nonmalignant pericardial disorders, dysrhythmias（including complete heart block，documented sustained ventricular tachycardia, ventricular fibrillation)

Time frame

2 month to 3 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

West China Second University Hospital

Lead sponsor

Source ClinicalTrials.gov

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