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| Name | Class |
|---|---|
| The General Hospital of Northern Theater Command | OTHER |
| Central China Fuwai Hospital of Zhengzhou University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Retrospective Cohort | Approximately 10,154 patients with coronary heart disease selected from an established cohort of 18,701 patients based on inclusion/exclusion criteria. | ||
| Prospective Cohort | At least 2,000 newly enrolled patients with coronary heart disease. Participants will be followed prospectively for thrombotic and bleeding events. |
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| Measure | Description | Time Frame |
|---|---|---|
| Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) | Composite of all-cause death, non-fatal myocardial infarction, ischemic stroke, and unplanned revascularization. | Up to 24 months after enrollment |
| Major Bleeding Events | Bleeding Academic Research Consortium (BARC) type 3 or type 5 bleeding. | Up to 24 months after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| All-Cause Death | Up to 24 months after enrollment | |
| Myocardial Infarction | Up to 24 months after enrollment | |
| Stroke |
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Inclusion Criteria:
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.
Exclusion Criteria:
For patients from the existing cohort:
For newly enrolled patients:
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The study population consists of patients with coronary heart disease who are receiving dual antiplatelet therapy after percutaneous coronary intervention. The study includes a retrospective cohort of approximately 10,154 patients with existing baseline and follow-up data and biospecimens, derived from a previously established patient cohort. In addition, a prospective cohort of at least 2,000 newly enrolled patients will be recruited.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xueyan Zhao, PhD | Contact | +86 13683185878 | zhao_xueyan@sina.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuwai Central China Cardiovascular Hospital | Recruiting | Zhengzhou | Henan | China |
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| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D006470 | Hemorrhage |
| D003324 | Coronary Artery Disease |
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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Peripheral venous blood samples, processed into plasma, serum, and DNA.
| Up to 24 months after enrollment |
| Stent Thrombosis | Up to 24 months after enrollment |
| General Hospital of Northern Theater Command of Chinese People's Liberation Army | Recruiting | Shenyang | Liaoning | 110016 | China |
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| Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College | Recruiting | Beijing | 100037 | China |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |