Risk Stratification Value of Biomarkers in Patients With Myocarditis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Myocarditis. Basic parameters: 3 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Risk Stratification Value of Biomarkers in Patients With Myocarditis (FORWARD): a National, Multicenter, Retrospective-prospective, Cohort Study
Overview
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.
Primary outcome measures
- Change in the incidence of MACCE [Time frame: 1, 3, 6 months after enrollment; and 1, 2, 3, 4, 5 years after enrollment.]
Secondary outcome measures (4)
- Change in the incidence of all-cause death [Time frame: 1, 3, 6 months after enrollment; and 1, 2, 3, 4, 5 years after enrollment.]
- Change in the incidence of myocardial infarction [Time frame: 1, 3, 6 months after enrollment; and 1, 2, 3, 4, 5 years after enrollment.]
- Change in the incidence of stroke [Time frame: 1, 3, 6 months after enrollment; and 1, 2, 3, 4, 5 years after enrollment.]
- Change in the incidence of coronary revascularization surgery [Time frame: 1, 3, 6 months after enrollment; and 1, 2, 3, 4, 5 years after enrollment.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- First Affiliated Hospital of Xi'an Jiaotong University — Xi'an
Identifiers
NCT: NCT06010199 · XJTU1AF2023LSK-169