NCT04498494

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
274

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 25, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 4, 2020

Completed
Last Updated

August 7, 2020

Status Verified

August 1, 2020

Enrollment Period

6 months

First QC Date

July 25, 2020

Last Update Submit

August 5, 2020

Conditions

Myocarditis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Atrioventricular block, ventricular tachycardia and their correlationwith Fulminant myocarditis (FM)

    through study completion, an average of 6 months

Study Arms (2)

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

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

Interventions

ECGDEVICE

12-lead ECG

fulminant myocarditismyocarditis

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

20 million residents of the South of Zhejiang Province

You may qualify if:

  • clinical diagnosis of Acute myocarditis
  • complete data of ECG

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

Location

Related Publications (2)

  • 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.

    PMID: 21304213BACKGROUND

  • 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.

    PMID: 23824828BACKGROUND

MeSH Terms

Conditions

Myocarditis

Interventions

Electrocardiography

Condition Hierarchy (Ancestors)

CardiomyopathiesHeart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisElectrodiagnosis

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
principal Investigator

Study Record Dates

First Submitted

July 25, 2020

First Posted

August 4, 2020

Study Start

January 1, 2019

Primary Completion

July 1, 2019

Study Completion

January 1, 2020

Last Updated

August 7, 2020

Record last verified: 2020-08

Locations

CN(1)