Multicenter Retrospective Observational Study of Acute Myocarditis in Korea

Sponsor

Samsung Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT05933902

Collaborator

Chonnam National University Hospital (Other), Sejong General Hospital (Other), Keimyung University Dongsan Medical Center (Other), Korea University Anam Hospital (Other), Asan Medical Center (Other)

841

Enrollment

Location

9.5

Actual Duration (Months)

88.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In this study, the investigators analyze the clinical characteristics and prognosis of patients with acute myocarditis in South Korea

Condition or Disease	Intervention/Treatment	Phase
Myocarditis Acute

Detailed Description

Acute myocarditis refers to a condition in which inflammatory cells infiltrate the heart muscle due to various causes. Until now, there is no clear treatment method for myocarditis itself, and when myocardial function deteriorates or arrhythmia occurs due to myocarditis, it is common to wait for natural recovery while performing general supportive treatment for heart failure.

Through this study, the investigators analyze the factors contributing to the long-term prognosis, myocardial recovery rate, and clinical course of myocarditis. And, the investigators plan to establish an appropriate treatment strategy necessary to increase the survival rate of patients with myocarditis.

Study Design

Study Type:

Observational

Actual Enrollment :

841 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Multicenter Retrospective Observational Study to Investigate the Characteristics and Prognosis of Patients With Acute Myocarditis in Korea

Actual Study Start Date :

Apr 12, 2022

Actual Primary Completion Date :

Jan 25, 2023

Actual Study Completion Date :

Jan 25, 2023

Outcome Measures

Primary Outcome Measures

Rate of In hospital mortality [through study completion, an average of 1 year]
In hospital death by any cause

Secondary Outcome Measures

Rate of all-cause mortality [through study completion, an average of 1 year]
Death by any cause during follow-up
Requirement of cardiac replacement therapy [through study completion, an average of 1 year]
Left ventricular assist device insertion or heart transplantation during follow-up
Rates of Re-hospitalization due to any cause [through study completion, an average of 1 year]
Re-hospitalization due to any cause during follow-up

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Typical myocarditis symptom and sign, such as fever, chest pain, chest discomfort or shortness of breath, accompanied by elevated myocardial enzymes
The above condition is satisfied and additional information is obtained through imaging such as cardiac MRI or cardiac biopsy

Exclusion Criteria:

● Coronary artery disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Samsung Medical Center	Seoul		Korea, Republic of	06351

Sponsors and Collaborators

Samsung Medical Center
Chonnam National University Hospital
Sejong General Hospital
Keimyung University Dongsan Medical Center
Korea University Anam Hospital
Asan Medical Center

Investigators

Study Chair: Jeong Hoon Yang, Samsung Medical Center

Study Documents (Full-Text)

Study Protocol and Statistical Analysis Plan - Jul 3, 2023

More Information

Publications

None provided.

Responsible Party:

Jeong Hoon Yang, Professor, Samsung Medical Center

ClinicalTrials.gov Identifier:

NCT05933902

Other Study ID Numbers:

2022-01-003-003

First Posted:

Jul 6, 2023

Last Update Posted:

Jul 6, 2023

Last Verified:

Jul 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Myocarditis

Study Results

No Results Posted as of Jul 6, 2023