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Clinical, Morphological and Functional Aspects in Myocarditis.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04217876
Recruitment Status : Completed
First Posted : January 6, 2020
Last Update Posted : January 6, 2020
Sponsor:
Collaborators:
Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
Humanitas Hospital, Italy
Vannini Hospital Rome
Information provided by (Responsible Party):
Gianluca Di Bella, University of Messina

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.

Condition or disease Intervention/treatment
Myocarditis Diagnostic Test: post-processing analysis of cardiac imaging (strain echocardiography)

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.

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Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Clinical, Morphological and Functional Aspects in Acute and Chronic Myocarditis.
Actual Study Start Date : December 2016
Actual Primary Completion Date : December 2019
Actual Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Clinically suspected infarct-like acute myocarditis
Diagnosis of infarct-like AM was based on five criteria: (a) history of flu-like symptoms within 8 weeks prior admission; (b) new onset of symptoms such as fatigue/breathlessness, chest pain, mild dyspnea, and/or palpitation; (c) ischemic ECG pattern (ST-segment elevation and/or T-wave anomalies); (d) increase of inflammatory markers (non-high- sensitivity CRP > 8 mg/L and/or white blood cell count > 11.000/mm3) and cardiac enzymes; and (e) preserved global systolic function (EF > 50%). We excluded patients with New York Heart Association (NYHA) functional heart classifications II-IV, LVEF < 50% and those patients with electrocardiographic evidence of bradyarrhythmias (≥second-degree atrioventricular block) or tachyarrhythmias (ventricular or supraventricular arrhythmias).
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.





Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Consecutive in-patients with a definite CMR diagnosis of AM having a follow-up CMR examination including cine CMR, T1, T2 weighted and LGE images.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04217876


Locations
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Italy
Lorenzo Monti
Milan, Italy, 20089
Alessandro Pingitore
Pisa, Italy, 56126
Giovanni D Aquaro
Pisa, Italy
Giovanni Camastra
Roma, Italy, 00177
Sponsors and Collaborators
University of Messina
Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
Humanitas Hospital, Italy
Vannini Hospital Rome
Investigators
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Principal Investigator: Gianluca Di Bella University of Messina, Italy
Study Chair: Mariapaola Campisi, MD University of Messina, Italy
Publications of Results:

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Responsible Party: Gianluca Di Bella, Associate Professor Cardiovascular Diseases, University of Messina
ClinicalTrials.gov Identifier: NCT04217876    
Other Study ID Numbers: 11616
First Posted: January 6, 2020    Key Record Dates
Last Update Posted: January 6, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gianluca Di Bella, University of Messina:
echocardiography
cardiac magnetic resonance
myocarditis
Additional relevant MeSH terms:
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Myocarditis
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases