Risk Stratification Value of Biomarkers in Patients With Myocarditis (FORWARD): a National, Multicenter, Retrospective-prospective, Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Change in the incidence of MACCE
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 3 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients should meet the diagnostic criteria for myocarditis
- •Patients who are regularly followed up at the corresponding cardiovascular center
排除标准
- •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
结局指标
主要结局
Change in the incidence of MACCE
时间窗: 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.
次要结局
- Change in the incidence of all-cause death(1, 3, 6 months after enrollment; and 1, 2, 3, 4, 5 years after enrollment.)
- Change in the incidence of myocardial infarction(1, 3, 6 months after enrollment; and 1, 2, 3, 4, 5 years after enrollment.)
- Change in the incidence of stroke(1, 3, 6 months after enrollment; and 1, 2, 3, 4, 5 years after enrollment.)
- Change in the incidence of coronary revascularization surgery(1, 3, 6 months after enrollment; and 1, 2, 3, 4, 5 years after enrollment.)