Diagnostic and Prognostic Prediction Models for Chinese Patients With Venous Thromboembolism
The DOMESTIC Study: Diagnostic and Prognostic Prediction Models for Patients With Venous Thromboembolism in China
研究概览
地位
详细说明
研究类型
注册 (预期的)
联系人和位置
学习联系方式
- 姓名：Dachun Xu, Ph.D
- 电话号码：0086-18917684045
- 邮箱：xdc77@tongji.edu.cn
研究联系人备份
- 姓名：Fan Wang, MD
- 电话号码：0086-15216717487
- 邮箱：15216717487@163.com
学习地点
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Shanghai
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Shanghai、Shanghai、中国、200072
- 招聘中
- Shanghai Tenth people's hospital, Tongji university
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
Development and validation of diagnostic prediction model:
Participants will undergo recruitment from the emergency department of five general urban hospitals in China, including Shanghai Tenth People's Hospital; Nanfang Hospital of Southern Medical University; First Affiliated Hospital, Sun Yat-Sen University; Zhongshan Hospital Xuhui Branch, Fudan University; Shanghai Baoshan Luo Dian Hospital; from March 1, 2019.
Development and validation of prognostic prediction model:
The investigators will identify patients with VTE from 5 thrombosis centers in China, including Shanghai Tenth People's Hospital; Nanfang Hospital of Southern Medical University; First Affiliated Hospital, Sun Yat-Sen University; Zhongshan Hospital Xuhui Branch, Fudan University; Shanghai Baoshan Luo Dian Hospital; between January 2014 and December 2018 using the Hospital Information Manage System(HIMS) database.
描述
Inclusion Criteria:
- > 18 years old
- First episode of PE and/or DVT (diagnosed by pulmonary angiogram, chest computed tomography pulmonary angiography(CTPA), Ventilation/Perfusion (V/Q) lung scan read as high probability by the radiologist, and/or (+) bilateral lower limb venous compression ultrasonography (CCUS))
Exclusion Criteria:
- Patients with prior VTE
- Cannot provide written informed consent
- Unable to read questionnaire in Chinese or English
- a record of pregnancy in the preceding 12 months
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
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Derivation Cohort
Derivation Cohort of Diagnostic Prediction Model: Participants will be recruited from the emergency department of five general urban hospitals in China, including Shanghai Tenth People's Hospital; Nanfang Hospital of Southern Medical University; First Affiliated Hospital, Sun Yat-Sen University; Zhongshan Hospital Xuhui Branch, Fudan University; Shanghai Baoshan Luo Dian Hospital; from March 1, 2019. The investigators will randomly assign 70% participants to a derivation cohort. Derivation Cohort of Prognostic Prediction Model: Patients with VTE from 5 thrombosis centers in China, including Shanghai Tenth People's Hospital; Nanfang Hospital of Southern Medical University; First Affiliated Hospital, Sun Yat-Sen University; Zhongshan Hospital Xuhui Branch, Fudan University; Shanghai Baoshan Luo Dian Hospital; between January 2014 and December 2018. |
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Validation Cohort
Validation Cohort of Diagnostic Prediction Model: The investigators plan to randomly assign 30% participants for developing the diagnostic prediction model to a Validation cohort. Validation Cohort of Prognostic Prediction Model: New individuals selected by the same inclusion and exclusion criteria as the derivation cohort of prognostic prediction model from the same institutions as a validation cohort of prognostic prediction model will be recruited from January 2019. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Death from all causes
大体时间：5-year
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Death from all causes during follow-up
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5-year
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Death from all causes
大体时间：30-day
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Death from all causes during hospitalization
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30-day
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Number of Participants with Recurrent VTE
大体时间：5-year
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Recurrent symptomatic DVT confirmed by venography or color duplex sonography or recurrent symptomatic pulmonary embolism confirmed by ventilation-perfusion scanning, CTPA, or pulmonary angiogram.
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5-year
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Number of Participants with Chronic Thromboembolic Pulmonary Hypertension(CTEPH)
大体时间：5-year
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CTEPH can be diagnosed by an echocardiogram or a CTPA.
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5-year
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Number of Participants with Cardiogenic Shock
大体时间：30-day
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Cardiogenic shock defined as hemodynamic instability(systolic blood pressure<90 mm Hg, or use of inotropic support）
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30-day
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合作者和调查者
赞助
合作者
调查人员
- 首席研究员：Dachun Xu, Ph.D、Shanghai 10th People's Hospital
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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