Clinical trial NCT04498494: The Role of Electrocardiograms in Risk Stratification and Analysis of the Characteristics of ST Elevation in Acute Myocarditis: a 2-centre Study
Official title: Role of Electrocardiograms in Risk Stratification and Analysis of the Characteristics of ST Elevation in Acute Myocarditis: A Two-center Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myocarditis
Lead sponsor: Wenzhou Medical University
Sponsor class: OTHER
First posted: 2020-08-04
Enrollment: 274
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 20 million residents of the South of Zhejiang Province

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The percentage rate of ST elevation
timeFrame: through study completion, an average of 2 years
Secondary outcomes:
measure: Atrioventricular block, ventricular tachycardia and their correlationwith Fulminant myocarditis (FM)
timeFrame: through study completion, an average of 6 months
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
Study officials:
References:
citation: JCS Joint Working Group. Guidelines for diagnosis and treatment of myocarditis (JCS 2009): digest version. Circ J. 2011;75(3):734-43. doi: 10.1253/circj.cj-88-0008. Epub 2011 Feb 4. No abstract available.
citation: Caforio AL, Pankuweit S, Arbustini E, Basso C, Gimeno-Blanes J, Felix SB, Fu M, Helio 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.