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Starting soon Observational

Prognostic Role of High Sensitivity Troponin During Follow up in the Evolution of Acute Myocarditis

NCT05949450 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2023-07
Last updated
2023-07-18

Condition(s) studied

Myocarditis

Study summary

The goal of this observational study is to observe if ultra-sensitive troponins (us) measurement between 3 and 6 months after the acute event will be sensitive enough to dispense with all other examinations, particularly cardiac magnetic resonance imaging (MRI), in patients suffering from myocarditis.

The investigators will collect patient events by telephone, once a year for 4 years.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Male or female patients over 18 years of age * Patients hospitalized at Grenoble Alpes University Hospital and Lyon University Hospital between June 2016 and June 2025 * Having presented chest pain and ≥1 diagnostic criteria or if no chest pain, presence of ≥2 diagnostic criteria below : * Electrical abnormalities (supra- or sub-ST, T-wave inversion, atrioventricular blocks 1-3 conduction disorders) * Elevation of cardiac biomarkers (troponin) * Kinetic abnormalities on cardiac ultrasound * Associated with ≥2 MRI criteria of tissue abnormality (edema, hyperhemia, myocardial fibrosis) * Patient affiliated to a social security scheme or beneficiary of such a scheme * No opposition to participation Exclusion Criteria: * Absence of documented coronary artery disease (cardiac CT or coronary angiography) or age \<30 and low risk of coronary artery disease. * Myocarditis secondary to immunotherapy. * Presence of documented coronary artery disease (coronary angiography or cardiac CT) * Presence of cardiomyopathy (hypertrophic cardiomyopathy, dilated cardiomyopathy) * Infiltrative heart disease (sarcoidosis or cardiac amyloidosis) * Severe valve disease * Takotsubo * Constrictive or chronic pericarditis * Loeffler's endocarditis * Non-compaction of the left ventricle * Cardiac tumor * Pulmonary embolism * Coronary spasm * Patients covered by articles L1121-5 to L1121-8 of the French Public Health Code (pregnant women, parturients, nursing mothers; persons deprived of liberty by judicial or administrative decision; protected adults)

Primary outcome measure(s)

  • Major Adverse Cardiac Events (MACE) rate at 4 years — 4 years
    MACE being defined by a composite criterion: 1) all-cause mortality, 2) cardiac decompensation requiring readmission, 3) cardiac transplantation,4) documented sustained ventricular arrhythmias \>30s, 5) recurrence of myocarditis.

Trial sites (1)

FacilityCityRegionStatus
Grenoble University Hospital La Tronche France
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05949450 on ClinicalTrials.gov ↗ ← All trials in France