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NCT Number: NCT05949450

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Major Adverse Cardiac Events (MACE) rate at 4 years

    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.

Secondary outcomes

  1. Troponin us measured at 3 to 6 months

    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.

  2. MACE apparition rate

    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.

  3. Troponin us measured 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.

  4. 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.

  5. Troponin Us measured at 3 to 6 months

    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.

  6. Presence of abnormality on frequency holter (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.

  7. cardiac MRI.

    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).

  8. Troponin Us measured at 3 and 6 months

    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).

  9. cardiac ultrasound measurements

    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).

  10. 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

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Clémence Charlon, MSc

CONTACT

[email protected]

0476766652

Gilles Barone-Rochette, MD, PhD

CONTACT

[email protected]

0476768888

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Collaborators

  • Hospices Civils de Lyon

Registry information

Official study title

Prognostic Role of Troponin Dosed at 3 to 6 Months in the Evolution of Acute Myocarditis

Acronym: PROGNOSTIC

Important dates

Study start
2023
Primary completion
2030
Study completion
2030
First posted
Jul 18, 2023
Registry last updated
Jul 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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