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NCT Number: NCT04217876

Clinical, Morphological and Functional Aspects in Myocarditis.

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.

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Key information

Conditions

Myocarditis Cardiomyopathies Cardiovascular Diseases Heart Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Lorenzo Monti, Milan, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

post-processing analysis of cardiac imaging (strain echocardiography)

Diagnostic Test

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.

Primary outcomes

  1. 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.

  2. 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

  1. Prognostic role of longitudinal dyfunction.

    Time frame: from 6-60 months

    cardiac 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

Sponsors and collaborators

Lead sponsor

University of Messina

Other

Collaborators

  • Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
  • Humanitas Hospital, Italy
  • Vannini Hospital Rome

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jan 6, 2020
Registry last updated
Jan 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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