Pre-warning Risk Scoring System for Sudden Cardiac Death
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100,000
- 试验地点
- 1
- 主要终点
- Sudden cardiac death
研究概览
简要总结
The goal of this observational study is to identify potential indicators for pre-warning of sudden cardiac death (SCD), including clinical biochemistry markers, electrocardiogram, echocardiography, MRI and CT imaging values, genetic markers and so on, and further construct a series of multi-parameter assessments of SCD early screening.
详细描述
In the past few decades, evidence-based drug and surgical treatment strategies have significantly improved the prevention of sudden cardiac death (SCD), however, a large number of patients with cardiovascular disease still face high risk of SCD, the prognosis of these high-risk SCD patients are still uncertain. Therefore, clinical physicians might need to move towards a multi-parameter assessment of SCD risk pre-warning. Several parameters for risk stratification of arrhythmia, including clinical biochemistry markers, electrocardiogram, echocardiography, imaging, and genetic markers, are crucial for accurate assessment of SCD risk stratification. In addition, the integration of cardiac magnetic resonance parameters and specific CT and ECG information is a future research trend for implementing risk stratification of malignant arrhythmias. In order to further explore the possibility of early warning of SCD, this study aims to include subjects with potential SCD risks, collect relevant potential SCD warning indicators, and then construct an SCD prewarning score system. Afterwards, the investigators will continuously improve the SCD warning score system based on follow-up information, and ultimately summarize an effective set of SCD warning scores and apply them to clinical practice, striving to achieve early warning of SCD and benefiting more people at risk of SCD.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The subjects with the following diagnosis of one or more cardiovascular diseases:
- •Coronary heart disease If there is a history of coronary heart disease or a new diagnosis of coronary heart disease, or with a report of coronary angiography that indicates at least one vascular stenosis>50%. Diagnosis includes chronic coronary syndrome (stable angina, ischemic cardiomyopathy, and occult coronary heart disease) and acute coronary syndrome (unstable angina, ST-segment elevation myocardial infarction and non-ST-segment elevation myocardial infarction).
- •Heart failure Individuals with a history of heart failure or newly diagnosed heart failure, including heart failure with reduced ejection fraction (HFrEF, left ventricular ejection fraction (LVEF) ≤40%)、intermediate heart failure (HFmrEF, LVEF 41%-49%，with evidence of spontaneous or excitable increase in left ventricular filling pressure), and ejection fraction preserving heart failure (HFpEF, LVEF≥50%, there is evidence of spontaneous or excitable increase in left ventricular filling pressure).
- •Genetically related cardiomyopathy or arrhythmia Cardiomyopathy includes hypertrophic cardiomyopathy (DCM), dilated cardiomyopathy (HCM), arrhythmogenic right ventricular cardiomyopathy (ARVC), inflammatory cardiomyopathy (myocarditis, sarcoidosis, Chagas disease). Hereditary arrhythmias include long QT syndrome, short QT syndrome, Brugada syndrome, idiopathic ventricular fibrillation, catecholamine sensitive polymorphic ventricular tachycardia (CPVT), early repolarization syndrome, etc.
- •Sign an informed consent form.
排除标准
- •Age<16 years old;
- •Refusal to the follow-up visits;
- •Individuals with severe mental disorders who are unable to express their wishes;
- •Other obvious physical diseases and abnormal laboratory test results;
- •Patients deemed unsuitable for participation in this study by the supervising physician.
结局指标
主要结局
Sudden cardiac death
时间窗: Baseline and to the 1-year, 2-year, 5-year follow-up
Identify participants who die by cardiovascular diseases during follow-up period
次要结局
- Cardiac arrest(Baseline and to the 1-year, 2-year, 5-year follow-up)
- All-causes death(Baseline and to the 1-year, 2-year, 5-year follow-up)
- Recurrence of cardiovascular disease(Baseline and to the 1-year, 2-year, 5-year follow-up)
- Major cardiovascular events(Baseline and to the 1-year, 2-year, 5-year follow-up)
研究者
Jingfeng Wang
Professor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University