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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

244 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-31

Study Completion Date

2030-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Diagnostic Evaluation of Out-of-hospital High-sensitivity Troponin I in Patients Presenting Chest Pain

NCT04950244

Chest Pain

COMPLETED

MYocardial DOmmages Related to COVID-19

NCT04498065

Covid19 Non Ischemic Myocardial Injury Myocardial Infarction +2 more

COMPLETED

Angioplasty to Blunt the Rise of Troponin in Acute Coronary Syndrome (ACS)

NCT00442949

Acute Coronary Syndrome

COMPLETED NA

Place of Copeptin-troponin Assay in the Elimination Diagnosis of Non-ST+ ACS

NCT05902117

Acute Myocardial Infarction

COMPLETED NA

Quantification and Description of the Increase in Serum Troponin Following Acute Coronary Syndrome

NCT01698021

Acute Coronary Syndrome Myocardial Infarction Unstable Angina

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Myocarditis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No