Risk Stratification Value of Biomarkers in Patients With Myocarditis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Risk Stratification Value of Biomarkers in Patients With Myocarditis (FORWARD): a National, Multicenter, Retrospective-prospective, Cohort Study

Conditions
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Myocarditis

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Myocarditis group<br>All enrolled patients are administered antiviral drugs, glucocorticoids, immunoglobulins, and other standard treatments. Additionally, the decision to provide ECMO support therapy is based on the severity of the patient's condition. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the incidence of MACCE | 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. | 1, 3, 6 months after enrollment; and 1, 2, 3, 4, 5 years after enrollment. | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myocarditis, Biomarker, Risk stratification