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Not Yet RecruitingNCT05949450

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

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

Status
Not Yet Recruiting
Phase
Study type
Observational
Enrollment
244 (estimated)
Sponsor
University Hospital, Grenoble · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Timeline

Start date
2023-07-01
Primary completion
2030-01-01
Completion
2030-07-01
First posted
2023-07-18
Last updated
2023-07-18

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT05949450. Inclusion in this directory is not an endorsement.