Prognostic Impact of Cardiac Imaging During Suspected Immune Checkpoint Inhibitor Myocarditis

  • STATUS
    Recruiting
  • End date
    Mar 30, 2024
  • participants needed
    100
  • sponsor
    Assistance Publique Hopitaux De Marseille
Updated on 30 October 2021
electrocardiogram
chest pain
arrhythmia

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.

Description

Patient with a risk of preterm labor (ultrasound cervical length < 25 mm +/- described or recorded uterine contractions) before 32 weeks of gestation will be hospitalized to receive tocolytic drugs and antenatal corticosteroid therapy according to the investigators gold standard protocol. After 48 hours, the participants will be assessed by examination, external tocodynamometry and the measure of cervical length by ultrasound. Stabilized patients will be included and randomized into 2 groups of 210 patients each. The first group "A" will benefit from the standard protocol (extended hospitalization of 2 or 4 days according to the clinical and ultrasound assessment); whereas the second group, "B", will have the benefit of the detection of phIGFBP-1.If the result proves negative, patients could be discharged early at day 2. In the case of a positive result, patients will follow the standard procedure because of the low positive predictive value of the test. The main outcome is the total duration of hospitalization.

Details
Condition Myocarditis, Cardiomyopathy
Clinical Study IdentifierNCT05086146
SponsorAssistance Publique Hopitaux De Marseille
Last Modified on30 October 2021

Eligibility

Yes No Not Sure

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
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