Grenoble University Hospital
La Tronche, 38700, France
NCT Number: NCT05949450
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
La Tronche, 38700, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Contact information is provided by the study sponsor or research team.
Clémence Charlon, MSc
CONTACT
Gilles Barone-Rochette, MD, PhD
CONTACT
University Hospital, Grenoble
Other
Prognostic Role of Troponin Dosed at 3 to 6 Months in the Evolution of Acute Myocarditis
Acronym: PROGNOSTIC
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