Risk Stratification Value of Biomarkers in Patients With Myocarditis

Recruiting

• Conditions: Myocarditis

• Registration Number: NCT06010199
• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University

Brief Summary

The aim of this study is to collect clinical data and biological specimens from patients with myocarditis and construct a predictive model for the prognosis of myocarditis.

Detailed Description

The aim of this study is to retrospectively and prospectively collect clinical data and biological specimens from patients with myocarditis who meet the inclusion and exclusion criteria. General molecular biology analysis, genome sequencing, transcriptome sequencing, methylation sequencing, metabolomics analysis, proteomics analysis, genome-wide chromosome conformation capture and other techniques are used to construct a prognosis prediction model for myocarditis.

Study Timeline

• Study First Submitted: 2023-07-06
• Study First Submitted QC: 2023-08-17
• Study First Posted: 2023-08-24
• Study Start: 2023-08-25
• Status Verified: 2024-03
• Last Update Submitted: 2024-07-10
• Last Update Posted: 2024-07-12
• Primary Completion: 2030-07-31
• Study Completion: 2030-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• All patients should meet the diagnostic criteria for myocarditis
• Patients who are regularly followed up at the corresponding cardiovascular center

Exclusion Criteria

• Age <3 years or >80 years
• Pregnant or lactating women
• The patient refused to sign the informed consent and refused to participate in the study
• None of the above is consistent, but the patient cannot sign the informed consent temporarily due to coma and other reasons, and there is no legal representative to sign it instead. Depending on the condition, the patient may not wake up to sign the informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in the incidence of MACCE	1, 3, 6 months after enrollment; and 1, 2, 3, 4, 5 years after enrollment.	MACE (major adverse cardiovascular events) including all-cause death, myocardial infarction, stroke and coronary revascularization surgery. The MACCE will be assessed from the medical records.

Secondary Outcome Measures

Name	Time	Method
Change in the incidence of all-cause death	1, 3, 6 months after enrollment; and 1, 2, 3, 4, 5 years after enrollment.	All-cause death diagnosed by clinical doctors will be assessed from the medical records
Change in the incidence of myocardial infarction	1, 3, 6 months after enrollment; and 1, 2, 3, 4, 5 years after enrollment.	Myocardial infarction diagnosed by clinical doctors will be assessed from the medical records
Change in the incidence of stroke	1, 3, 6 months after enrollment; and 1, 2, 3, 4, 5 years after enrollment.	Stroke diagnosed by clinical doctors will be assessed from the medical records
Change in the incidence of coronary revascularization surgery	1, 3, 6 months after enrollment; and 1, 2, 3, 4, 5 years after enrollment.	Coronary revascularization surgery completed by clinical doctors will be assessed from the medical records

Trial Locations

Locations (1)

First Affiliated Hospital of Xi'an Jiaotong University; 🇨🇳 Xi'an, Shaanxi, China