The China Pulmonary Thromboembolism Registry Study (CURES)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 15,000
- 试验地点
- 1
- 主要终点
- Other adverse events at discharge
研究概览
简要总结
Epidemiological data on pulmonary embolism (PE) in China needs to be updated and reported. The China Pulmonary Thromboembolism Registry Study (CURES) is designed to provide the cross-sectional spectrum and chronological trends of PE in China, as well as to reveal the intrinsic etiology and pathogenesis of the disease. The CURES is an ongoing large prospective multicenter registry, which was originally initiated in January 2009 via enrolling suspected or confirmed PE or PE with DVT (deep venous thrombosis) patients and assessed their in-hospital outcomes from 100 medical centers in the China PE-DVT network. As of July 2011, in order to determine the PE-relevant short-term outcomes, enrolled participants were followed-up for at least three months in a longitudinal manner. Since August 2016, with the launch and development of precision medicine research scheme in China, the main principle investigators of CURES decided to collect enrolled patients' blood samples with regular follow-ups every three or six months for at least two years (for long-term outcomes). The study protocol has been approved by the China-Japan Friendship Hospital ethics committee, and all collaborating centers received approvals from their local ethics committee. All patients provided written or verbal informed consent to their participation.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Other adverse events at discharge
时间窗: Two years
Other adverse events at discharge include bleeding (fatal bleeding, major bleeding, clinically relevant non-major bleeding), rash, liver dysfunction, thrombocytopenia, stroke or transient cerebral ischemia, myocardial infarction or acute coronary syndrome, etc.
Clinical outcomes at discharge
时间窗: Two years
Clinical outcomes at discharge or during hospitalization include disease recovery or cure, deterioration due to VTE or other comorbidities, and death (mainly all-cause and PE-specific mortality)
Short-term (three months) and long-term (beyond three months and further forwards) clinical outcomes
时间窗: Two years
Clinical outcomes during short-term and long-term follow-ups include condition improvement or remission, recurrence of VTE (PE and DVT), chronic thromboembolic pulmonary hypertension (CTEPH), and death (mainly all-cause and PE-specific mortality)
次要结局
未报告次要终点
研究者
Zhenguo Zhai,MD,PhD
Ph.D, MD, Professor of Pulmonary and Critical Care Medicine
China-Japan Friendship Hospital
