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Completed

NCT Number: NCT04498494

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

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

About this study

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.

Who can participate

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

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.

Treatment and study plan

ECG

Device

12-lead ECG

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Yuanli Lei

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Aug 4, 2020
Registry last updated
Aug 7, 2020

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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