The Role of Electrocardiograms in Risk Stratification and Analysis of the Characteristics of ST Elevation in Acute Myocarditis: a 2-centre Study

August 5, 2020 updated by: Yuanli Lei

Role of Electrocardiograms in Risk Stratification and Analysis of the Characteristics of ST Elevation in Acute Myocarditis: A Two-center Study

The purpose of the present study was to investigate ECG findings of patients with acute myocarditis, ECG findings associated with fulminant myocarditis, and the characteristics of ST-elevation on admission.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Acute myocarditis is a severe disease with high mortality rate and various dynamic changes visible on electrocardiograms (ECGs). The aim were to investigate ECG findings in acute myocarditis, ECG findings associated with fulminant myocarditis (FM), and the characteristics of ST elevation at admission. A retrospective analysis of 1814 ECGs was conducted from 274 consecutive patients with acute myocarditis aged ≥13 years, who were hospitalized in two centres between August 2007 and November 2019. All ECG obtained during the hospital course were evaluated by 2 electrophysiologists. A chi-square test was used to evaluate and compare the abnormal ECG findings between the FM and non-FM groups, and multivariate logistic regression analysis was performed to further evaluate ECG findings associated with FM. The Mann-Whitney U test was used to compare the duration of cardiac symptoms before admission for ST elevation at admission.

Study Type

Observational

Enrollment (Actual)

274

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

  • China
    • Zhejiang
      • Wenzhou, Zhejiang, China, 325000
        • The First Affiliated Hospital of Wenzhou Medical University

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

20 million residents of the South of Zhejiang Province

Description

Inclusion Criteria:

  • clinical diagnosis of Acute myocarditis

    • complete data of ECG

Exclusion Criteria :

  • Incomplete data;

    • a history of congenital heart disease, cardiomyopathy or arrhythmias;

      • myocarditis not being the primary diagnosis for a particular admission;

        • absence of cardiac symptoms.

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
myocarditis
The diagnosis of acute myocarditis was confirmed by a recent history of gastrointestinal/upper respiratory tract infection and/or complaints of cardiac symptoms and increasing cardiac markers and/or presentation with a new abnormality of the 12-lead ECGcombined with at least one of the following: ⅰ) Active or borderline biopsy according to the Dallas criteria (13); ⅱ) positive infectious origin of ventricular dysfunction; ⅲ) delayed enhancement on cardiac MRI consistent with myocarditis; or ⅳ) serological tests, ECGs, ultrasonic cardiogram (UCG), coronary angiography and ventriculography to exclude acute myocardial infarction (AMI), stress cardiomyopathy, congenital heart disease, myocarditis secondary to sepsis, valve disease, hyperthyroidism, autoimmune disease and rheumatic fever
Device: ECG
12-lead ECG
fulminant myocarditis
In patients with acute myocarditis, a diagnosis of FM was determined upon identification of one or more of the following: Haemodynamic instability due to cardiogenic shock or arrhythmia; left ventricular dysfunction and low cardiac output syndrome requiring inotropes or mechanical circulatory support; mechanical ventilation; and/or cardiac arrest (CA)
Device: ECG
12-lead ECG

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The percentage rate of ST elevation
Time Frame: through study completion, an average of 2 years
ST elevation was the typical ECG changes of acute myocarditis. The study was to investigate how many patients presented with ST elevation on admission.
through study completion, an average of 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Atrioventricular block, ventricular tachycardia and their correlationwith Fulminant myocarditis (FM)
Time Frame: through study completion, an average of 6 months
FM is a peculiar clinical condition and is an acute and severe form of myocarditis . FM is associated with a wide variety of ECG findings. The study was to investigate Atrioventricular block, ventricular tachycardia and their correlation with FM.
through study completion, an average of 6 months

Collaborators and Investigators

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

Sponsor

Yuanli Lei

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)

January 1, 2019

Primary Completion (ACTUAL)

July 1, 2019

Study Completion (ACTUAL)

January 1, 2020

Study Registration Dates

First Submitted

July 25, 2020

First Submitted That Met QC Criteria

July 30, 2020

First Posted (ACTUAL)

August 4, 2020

Study Record Updates

Last Update Posted (ACTUAL)

August 7, 2020

Last Update Submitted That Met QC Criteria

August 5, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Yuanli2020

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.

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