Prognostic Impact of Cardiac Imaging During Suspected Immune Checkpoint Inhibitor Myocarditis

NCT05086146 | Unknown

• 2 other identifiers: 2020-632020-A03384-35
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Myocarditis

Outcome Measures

Primary Outcomes (1)

• Cumulative incidence rate of the composite end point

  including cardiovascular death, acute heart failure, cardiogenic shock, cardiac arrest, sustained ventricular tachycardia, ventricular fibrillation, 2nd-degree (except Mobitz 1) or 3rd-degree atrioventricular block.

  6-month

Secondary Outcomes (1)

• Cumulative incidence rate of all-cause death

  6-month

Eligibility Criteria

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

Study Population

all patients with suspected myocarditis on ICIs.

You may qualify if:

• 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
• Translated with www.DeepL.com/Translator (free version)

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

assistance publique hôpitaux de Marseille

Marseille, 13354, France

RECRUITING

MeSH Terms

Conditions

Myocarditis

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases

Study Officials

• François CREMIEUX

  Assistance Publique Hopitaux De Marseille

  STUDY DIRECTOR

Central Study Contacts

DEHARO PIERRE

CONTACT

(0)4 91 96 86 83; pierre.deharo@ap-hm.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2021
• First Posted: October 20, 2021
• Study Start: August 10, 2021
• Primary Completion: September 1, 2023
• Study Completion: March 1, 2024
• Last Updated: October 20, 2021

Record last verified: 2021-10

Locations

FR (1)