Multicenter Retrospective Observational Study of Acute Myocarditis in Korea

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

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

Study Overview

• Status: Completed
• Conditions: 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 Type: Observational
• Enrollment (Actual): 841

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with acute myocarditis at 6 domestic hospitals in South Korea from January 2004 to December 2021

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of In hospital mortality	In hospital death by any cause	through study completion, an average of 1 year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Collaborators: Asan Medical Center; Chonnam National University Hospital; Korea University Anam Hospital; Keimyung University Dongsan Medical Center; Sejong General Hospital
• Investigators: Study Chair: Jeong Hoon Yang, Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2022
• Primary Completion (Actual): January 25, 2023
• Study Completion (Actual): January 25, 2023

Study Registration Dates

• First Submitted: May 12, 2023
• First Submitted That Met QC Criteria: July 3, 2023
• First Posted (Actual): July 6, 2023

Study Record Updates

• Last Update Posted (Actual): July 6, 2023
• Last Update Submitted That Met QC Criteria: July 3, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Cardiomyopathies; Myocarditis
• Other Study ID Numbers: 2022-01-003-003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No