The DOMESTIC Study: Diagnostic and Prognostic Prediction Models for Patients With Venous Thromboembolism in China
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 4,000
- 试验地点
- 1
- 主要终点
- Death from all causes
研究概览
简要总结
The objective of this proposal is to develop and validate diagnostic and prognostic (including short-term and long-term prognoses) prediction models for patients with venous thromboembolism (VTE) in China.
详细描述
Venous thromboembolism (VTE), which clinically manifests as deep vein thrombosis (DVT) and pulmonary embolism (PE), is one of the leading causes of mortality that need to be accurately diagnosed and effectively managed. Although a number of clinical decision rules in the domain of VTE have been presented in the literature, such as the well-known prediction models developed by Wells and colleagues, the prognostic models to assess VTE recurrence risk in patients who suffered from a VTE or the Pulmonary Embolism Severity Index (PESI) for short-term mortality risk in PE patients, and various other diagnostic models for both DVT and PE. They are few designed for Chinese patients. The primary objective of this proposal is to develop and validate diagnostic and prognostic (including short-term and long-term prognoses) prediction models for patients with VTE in China.
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
- •> 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))
排除标准
- •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
结局指标
主要结局
Death from all causes
时间窗: 30-day
Death from all causes during hospitalization
次要结局
- Number of Participants with Recurrent VTE(5-year)
- Number of Participants with Chronic Thromboembolic Pulmonary Hypertension(CTEPH)(5-year)
研究者
Ya-Wei Xu
Head of Cardiology
Shanghai 10th People's Hospital
