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

Myocarditis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04498494
• Other study ID #: Yuanli2020
• Status: Completed
• Start date: January 1, 2019
• Est. completion date: January 1, 2020

Study information

• Verified date: August 2020
• Source: Wenzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 274
• Est. completion date: January 1, 2020
• Est. primary completion date: July 1, 2019
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Myocarditis

Intervention

Device:
• ECG
12-lead ECG

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Wenzhou Medical University	Wenzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Yuanli Lei

Country where clinical trial is conducted

China, 

References & Publications (2)

Caforio AL, Pankuweit S, Arbustini E, Basso C, Gimeno-Blanes J, Felix SB, Fu M, Heliö T, Heymans S, Jahns R, Klingel K, Linhart A, Maisch B, McKenna W, Mogensen J, Pinto YM, Ristic A, Schultheiss HP, Seggewiss H, Tavazzi L, Thiene G, Yilmaz A, Charron P, Elliott PM; European Society of Cardiology Working Group on Myocardial and Pericardial Diseases. Current state of knowledge on aetiology, diagnosis, management, and therapy of myocarditis: a position statement of the European Society of Cardiology Working Group on Myocardial and Pericardial Diseases. Eur Heart J. 2013 Sep;34(33):2636-48, 2648a-2648d. doi: 10.1093/eurheartj/eht210. Epub 2013 Jul 3. — View Citation

JCS Joint Working Group. Guidelines for diagnosis and treatment of myocarditis (JCS 2009): digest version. Circ J. 2011;75(3):734-43. Epub 2011 Feb 4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percentage rate of ST elevation	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	Atrioventricular block, ventricular tachycardia and their correlationwith Fulminant myocarditis (FM)	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