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Clinical, Morphological and Functional Aspects in Myocarditis.

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04217876
Enrollment
200
Registered
2020-01-06
Start date
2016-12-31
Completion date
2019-12-31
Last updated
2020-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocarditis

Keywords

echocardiography, cardiac magnetic resonance, myocarditis

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.

Interventions

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.

Sponsors

Fondazione C.N.R./Regione Toscana G. Monasterio, Pisa, Italy
CollaboratorOTHER_GOV
Humanitas Hospital, Italy
CollaboratorOTHER
Vannini Hospital Rome
CollaboratorUNKNOWN
University of Messina
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Demonstrating incidence of longitudinal dysfunction of left ventricle in patients with acute myocarditis and preserved ejection fraction.Day 0Longitudinal 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.Day 0Longitudinal 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

MeasureTime frameDescription
Prognostic role of longitudinal dyfunction.from 6-60 monthscardiac death, resuscitated cardiac arrest, ventricular assist device implantation, cardiac transplantation, appropriate implantable cardioverter defibrillator (ICD) shock, relapse of AM and hospitalization for worsening heart failure

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026