Clinical, Morphological and Functional Aspects in Myocarditis.

December 31, 2019 updated by: Gianluca Di Bella, University of Messina

Clinical, Morphological and Functional Aspects in Acute and Chronic 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy, 20089
        • Lorenzo Monti
      • Pisa, Italy, 56126
        • Alessandro Pingitore
      • Pisa, Italy
        • Giovanni D Aquaro
      • Roma, Italy, 00177
        • Giovanni Camastra

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 0
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.
Day 0

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
from 6-60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Messina

Collaborators

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

Investigators

  • Principal Investigator: Gianluca Di Bella, University of Messina, Italy
  • Study Chair: Mariapaola Campisi, MD, University of Messina, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2016

Primary Completion (ACTUAL)

December 1, 2019

Study Completion (ACTUAL)

December 1, 2019

Study Registration Dates

First Submitted

December 28, 2019

First Submitted That Met QC Criteria

December 31, 2019

First Posted (ACTUAL)

January 6, 2020

Study Record Updates

Last Update Posted (ACTUAL)

January 6, 2020

Last Update Submitted That Met QC Criteria

December 31, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11616 (Registry Identifier: DAIDS-ES)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Myocarditis

Clinical Trials on post-processing analysis of cardiac imaging (strain echocardiography)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Equatorial Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe