Multi-Omics-Based Development of Novel Thrombosis and Bleeding Markers and Construction of a Risk Prediction Model in Coronary Heart Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 12,154
- 试验地点
- 3
- 主要终点
- Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
研究概览
简要总结
Patients with coronary heart disease who take dual antiplatelet therapy face two serious risks: thrombosis and major bleeding. This study aims to develop better ways to predict these risks and guide personalized treatment.
The investigators will use a large, long-term follow-up study of Chinese patients with coronary heart disease. This research plans to discover new biomarkers related to clot and bleeding risk. The study will combine information from proteins, metabolites, sugars attached to proteins, genes, and medical images. Using machine learning methods, the investigators will identify the most important markers and test them in the patient group of this study.
The investigators will then build new risk prediction models that include these new markers together with traditional risk scores (such as GRACE, PARIS, and Precise-DAPT). This study will check whether these new models are better than existing ones at predicting who will develop clots or bleeding and at helping doctors decide on the best treatment for each patient.
The new aspects of this research are: (1) using advanced multi-omics technology to find novel markers specifically for Chinese patients; (2) combining clinical, biological, and imaging data to improve prediction accuracy; and (3) using machine learning to create more precise risk models.
The goal is to provide doctors with a more accurate tool to assess each patient's risk of clots and bleeding. This will help them choose the safest and most effective antiplatelet treatment, reduce serious complications, and improve patient care.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years.
- •Hospitalized due to symptoms or objective evidence of coronary heart disease and planned for long-term antithrombotic therapy.
- •Diagnosis of acute coronary syndrome or stable coronary heart disease undergoing percutaneous coronary intervention (PCI), with clinical stability meeting discharge criteria after treatment.
- •For patients from the existing cohort: minimum 2 years of follow-up with complete clinical data and blood specimens available; approval for use of these data and specimens has been obtained, with a waiver of re-consent.
- •For newly enrolled patients: voluntary written informed consent provided by the patient or legal representative, agreement to provide blood samples, and acceptance of follow-up procedures.
排除标准
- •For patients from the existing cohort:
- •Severe missing or erroneous baseline or clinical data that cannot be corrected by source verification.
- •No available blood specimen, or specimen that does not meet testing requirements.
- •For newly enrolled patients:
- •Presence of serious comorbid conditions with life expectancy ≤ 6 months.
- •Conditions that significantly affect study compliance or the ability to complete follow-up.
- •Contraindications to blood sampling.
研究组 & 干预措施
Prospective Cohort
At least 2,000 newly enrolled patients with coronary heart disease. Participants will be followed prospectively for thrombotic and bleeding events.
Retrospective Cohort
Approximately 10,154 patients with coronary heart disease selected from an established cohort of 18,701 patients based on inclusion/exclusion criteria.
结局指标
主要结局
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
时间窗: Up to 24 months after enrollment
Composite of all-cause death, non-fatal myocardial infarction, ischemic stroke, and unplanned revascularization.
Major Bleeding Events
时间窗: Up to 24 months after enrollment
Bleeding Academic Research Consortium (BARC) type 3 or type 5 bleeding.
次要结局
- All-Cause Death(Up to 24 months after enrollment)
- Myocardial Infarction(Up to 24 months after enrollment)
- Stroke(Up to 24 months after enrollment)
- Stent Thrombosis(Up to 24 months after enrollment)
研究者
Xueyan Zhao
Chief Physician
Chinese Academy of Medical Sciences, Fuwai Hospital