Myocarditis
Conditions
Keywords
myocarditis, troponine us
Brief 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.
Detailed description
Myocarditis is a frequent pathology with a heterogeneous initial clinical presentation. The long-term course of the disease is variable, with the possibility of healing and recovery, but also the likelihood of long-term deterioration, with the development of true dilated cardiomyopathy. While diagnostic criteria in the initial phase are well codified, notably with cardiac MRI, follow-up methods are less standardized. Re-evaluation between 3 and 6 months is not carried out by all teams, and if it is, the examinations performed vary from one team to another. Grenoble team has demonstrated the prognostic role of MRI reassessment at 3 and 6 months. It is also common to measure troponins to detect chronic myocarditis. However, this assay has evolved over time with the advent of ultra-sensitive troponins (us). These appear to be much more sensitive, and this increased sensitivity may lead to a change in care strategies. For example, in the management of chest pain in emergency departments before the era of us troponins, the use of coronary CT scans improved patient management. This benefit of imaging has disappeared since the advent of troponin us. The hypothesis of investigators is that troponin us measurement between 3 and 6 months after the acute event will be sensitive enough to dispense with all other examinations, particularly cardiac MRI, in order to identify patients at risk of poor prognosis.
Interventions
None listed
Sponsors
Hospices Civils de Lyon
University Hospital, Grenoble
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MACE apparition rate | 3 to 6 months | Prognostic value of troponin and MACE apparition. Troponin assays will be reported in ng/l. 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. The MACE rate will be counted to answer the objective. |
| watts generated on stress test at 3 to 6 months | 3 to 6 months | Prognostic value of Troponin us measured (in ng/l) at 3 to 6 months and watts generated on stress test at 3 to 6 months. Results of the stress test will be reported in watts. |
| Troponin Us measured at 3 to 6 months | 3 to 6 months | Prognostic value of Troponin Us (ng/l) measured at 3 to 6 months and presence of abnormality on frequency holter Presence of abnormality on frequency holter is defined by the transition to atrial fibrillation and/or unsustained or sustained ventricular tachycardia. |
| Presence of abnormality on frequency holter (transition to atrial fibrillation and/or unsustained or sustained ventricular tachycardia). | 3 to 6 months | Prognostic value of Troponin Us (ng/l) measured at 3 to 6 months and presence of abnormality on frequency holter Presence of abnormality on frequency holter is defined by the transition to atrial fibrillation and/or unsustained or sustained ventricular tachycardia. Presence of abnormality on frequency holter is defined by the transition to atrial fibrillation and/or unsustained or sustained ventricular tachycardia. |
| Troponin us measured at 3 to 6 months | 3 to 6 months | Prognostic value of troponin and MACE apparition. Troponin assays will be reported in ng/l. 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. The MACE rate will be counted to answer the objective. |
| Troponin Us measured at 3 and 6 months | 3 to 6 months | Relationship between Troponin Us measured at 3 and 6 months and cardiac ultrasound measurements and cardiac MRI. Cardiac ultrasound measurements (longitudinal, radial and circumferential strain of the left ventricle in speckle tracking, left atrial strain in speckle tracking) Data collected during cardiac MRI are right and left ventricular function in percentage, cardiac mass in gram, and percentage of left ventricular fibrosis). |
| cardiac ultrasound measurements | 3 to 6 months | Relationship between Troponin Us measured at 3 and 6 months and cardiac ultrasound measurements and cardiac MRI. Cardiac ultrasound measurements (longitudinal, radial and circumferential strain of the left ventricle in speckle tracking, left atrial strain in speckle tracking) Data collected during cardiac MRI are right and left ventricular function in percentage, cardiac mass in gram, and percentage of left ventricular fibrosis). |
| The rate of occurrence of the following events at 30 days: ventricular arrhythmias, heart failure, need for heart transplantation, need for circulatory support, recovered cardiorespiratory arrest, all-cause mortality | 30 days | Relationship between Troponin Us measured at 3 and 6 months and cardiac ultrasound measurements and cardiac MRI. Cardiac ultrasound measurements (longitudinal, radial and circumferential strain of the left ventricle in speckle tracking, left atrial strain in speckle tracking) Data collected during cardiac MRI are right and left ventricular function in percentage, cardiac mass in gram, and percentage of left ventricular fibrosis). |
| cardiac MRI. | 3 to 6 months | Relationship between Troponin Us measured at 3 and 6 months and cardiac ultrasound measurements and cardiac MRI. Cardiac ultrasound measurements (longitudinal, radial and circumferential strain of the left ventricle in speckle tracking, left atrial strain in speckle tracking) Data collected during cardiac MRI are right and left ventricular function in percentage, cardiac mass in gram, and percentage of left ventricular fibrosis). |
Countries
France
Contacts
Primary ContactGilles Barone-Rochette, MD, PhD
Backup ContactClémence Charlon, MSc
Outcome results
None listed