跳至主要内容
临床试验/NCT03802929
NCT03802929招募中不适用

The DOMESTIC Study: Diagnostic and Prognostic Prediction Models for Patients With Venous Thromboembolism in China

Ya-Wei Xu1 个研究点 分布在 1 个国家目标入组 4,000 人开始时间: 2019年6月1日最近更新:
适应症

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

发起方
Ya-Wei Xu
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ya-Wei Xu

Head of Cardiology

Shanghai 10th People's Hospital

研究点 (1)

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