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Clinical Trials/NCT04217876
NCT04217876
Completed
Not Applicable

Clinical, Morphological and Functional Aspects in Acute and Chronic Myocarditis.

University of Messina4 sites in 1 country200 target enrollmentDecember 2016
ConditionsMyocarditis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Myocarditis
Sponsor
University of Messina
Enrollment
200
Locations
4
Primary Endpoint
Demonstrating incidence of longitudinal dysfunction of left ventricle in patients with acute myocarditis and preserved ejection fraction.
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

Cardiac magnetic resonance (CMR) is accurate to identify acute myocardial damage (edema, hyperemia, and/or fibrosis) due to acute myocarditis (AM). Recently, two-dimensional strain echocardiography was also validated in order to provide important information on myocardial dysfunction in patients with AM, even if no wall motion abnormalities are detected. No data are available about incidence of longitudinal myocardial dysfunction and its prognostic role in AM.

Detailed Description

In this study, the investigators will analyze the effect of acute myocarditis-induced damage on LV myocardial deformation and remodeling both in the acute myocarditis phase and follow-up period (about 2 years later). The investigators will use a combined approach including strain echocardiography to asses left ventricular myocardial deformation and late gadolinium enhancement (LGE)cardiac magnetic resonance for the assessment of left ventricular damage.

Registry
clinicaltrials.gov
Start Date
December 2016
End Date
December 2019
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Gianluca Di Bella

Associate Professor Cardiovascular Diseases

University of Messina

Eligibility Criteria

Inclusion Criteria

  • diagnosis of clinical suspected acute myocarditis (AM)
  • diagnosis of AM with cardiac magnetic resonance (CMR) according to Lake Louise criteria (myocardial edema, hyperemia, and LGE).
  • absence of coronary artery diseases confirmed by coronary angiography or computed tomography in all patients with the exception of those younger than 30 years with a low risk of coronary artery disease.

Exclusion Criteria

  • Previous heart diseases

Outcomes

Primary Outcomes

Demonstrating incidence of longitudinal dysfunction of left ventricle in patients with acute myocarditis and preserved ejection fraction.

Time Frame: Day 0

Longitudinal systolic function (s-1) of the left ventricle will be measured (%) by echocardiography.

Demonstrating effect of myocarditis damage due to myocardial fibrosis on longitudinal function.

Time Frame: Day 0

Longitudinal systolic function (s-1) of the left ventricle will be measured (%) by echocardiography. Myocardial fibrosis LGE was defined as myocardium with an signal intensity higher than the average signal intensity of the region of interest more than 6 standard deviation in late gadolinium enhancement technique.

Secondary Outcomes

  • Prognostic role of longitudinal dyfunction.(from 6-60 months)

Study Sites (4)

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