Clinical Trials Directory

Trials / Completed

CompletedNCT04217876

Clinical, Morphological and Functional Aspects in Myocarditis.

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

Status
Completed
Phase
Study type
Observational
Enrollment
200 (actual)
Sponsor
University of Messina · Academic / Other
Sex
All
Age
18 Years – 90 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTpost-processing analysis of cardiac imaging (strain echocardiography)A dedicated software package for two-dimensional speckle tracking strain analysis (XStrain™, Esaote, Florence, Italy) was used to quantify both ENDO and EPI strains. Our echocardiographic imaging acquisition protocol for 2DSTE consisted in the acquisition of three consecutive cardiac cycles from non-foreshortened apical views (4, 2, and 3 chambers) obtained during breath hold. Frame-by- frame displacement of ENDO and EPI points was automatically evaluated, generating strain curves for each segment. The tracking quality was verified for each segment, and subsequent manual adjustments were performed, when required. All data were analyzed with the aid of Fourier techniques, which ensure greater accuracy using the periodicity of the heart motion.

Timeline

Start date
2016-12-01
Primary completion
2019-12-01
Completion
2019-12-01
First posted
2020-01-06
Last updated
2020-01-06

Locations

4 sites across 1 country: Italy

Source: ClinicalTrials.gov record NCT04217876. Inclusion in this directory is not an endorsement.