Multicenter Retrospective Observational Study of Acute Myocarditis in Korea

Myocarditis Acute Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05933902
• Other study ID #: 2022-01-003-003
• Status: Completed
• Start date: April 12, 2022
• Est. completion date: January 25, 2023

Study information

• Verified date: July 2023
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 841
• Est. completion date: January 25, 2023
• Est. primary completion date: January 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Myocarditis
• Myocarditis Acute

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (6)

Lead Sponsor	Collaborator
Samsung Medical Center	Asan Medical Center, Chonnam National University Hospital, Keimyung University Dongsan Medical Center, Korea University Anam Hospital, Sejong General Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of In hospital mortality	In hospital death by any cause	through study completion, an average of 1 year
Secondary	Rate of all-cause mortality	Death by any cause during follow-up	through study completion, an average of 1 year
Secondary	Requirement of cardiac replacement therapy	Left ventricular assist device insertion or heart transplantation during follow-up	through study completion, an average of 1 year
Secondary	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