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
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | post-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.