Prognostic Impact of Cardiac Imaging During Suspected Immune Checkpoint Inhibitor Myocarditis (NCT05086146) | Clinical Trial Compass
UnknownNot Applicable
Prognostic Impact of Cardiac Imaging During Suspected Immune Checkpoint Inhibitor Myocarditis
France100 participantsStarted 2021-08-10
Plain-language summary
It consists of evaluating the advantage of routine detection of phIGFBP-1 to reduce the total duration of hospitalization for patients with a risk of preterm labor before 32 weeks of gestation without increasing the number of preterm labour.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
All patients affiliated to the French social security system will be eligible, after signing a consent form, and presenting the following criteria
* Introduction within the last 3 months of at least one of the following ICIs: nivolumab, pembrolizumab, cemiplimab, avelumab, atezolizumab, ipilimumab, tremelimumab, durvalumab.
* Suspicion of myocarditis defined by the presence of at least one of the following criteria adapted from the European Society of Cardiology guidelines:
* Symptomatic patients (chest pain, dyspnea, palpitations, syncope/lipothymia) within 7 days of ICI administration
* New ECG abnormality (ST-segment elevation, ST-segment undershift, arrhythmia, conductive disturbances, T-wave inversion)
* Elevation of troponin above the 99th percentile of the laboratory reference value or, if troponin is already elevated before treatment, an increase of more than 30% of the baseline value
* Recent LVEF decline or recent LV contraction abnormality on a TTE
* Patient has given no objection
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Exclusion Criteria:
* Age \<18 years
* Major under guardianship or curatorship
* Pregnant or breastfeeding women
* Patient not covered by a social security plan
* Hemodynamic or rhythmic instability
* Estimation of glomerular filtration rate by the MDRD formula \<30ml/min/1.73m2
* Implantable equipment that does not allow for cMRI
What they're measuring
1
Cumulative incidence rate of the composite end point