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

Sponsor
Yuanli Lei (Other)
Overall Status
Completed
CT.gov ID
NCT04498494
Collaborator
(none)
274
1
12
22.8

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: ECG

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 Design

Study Type:
Observational
Actual Enrollment :
274 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
Role of Electrocardiograms in Risk Stratification and Analysis of the Characteristics of ST Elevation in Acute Myocarditis: A Two-center Study
Actual Study Start Date :
Jan 1, 2019
Actual Primary Completion Date :
Jul 1, 2019
Actual Study Completion Date :
Jan 1, 2020

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. The percentage rate of ST elevation [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.

Secondary Outcome Measures

  1. Atrioventricular block, ventricular tachycardia and their correlationwith Fulminant myocarditis (FM) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 The First Affiliated Hospital of Wenzhou Medical University Wenzhou Zhejiang China 325000

Sponsors and Collaborators

  • Yuanli Lei

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Yuanli Lei, principal Investigator, Wenzhou Medical University
ClinicalTrials.gov Identifier:
NCT04498494
Other Study ID Numbers:
  • Yuanli2020
First Posted:
Aug 4, 2020
Last Update Posted:
Aug 7, 2020
Last Verified:
Aug 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 7, 2020