The Prevalence of Pulmonarym Embolism in Patients With the First Episode of Syncope
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- To assess the prevalence of PE in a large series of consecutive patients presenting with the first episode of syncope
研究概览
简要总结
All patients consecutively referred with the first episode of transient and short-lasting loss of consciousness will have a diagnostic workup for the assessment of the most common causes of syncope, and will be evaluated for the presence of pulmonary embolism (PE) with the use of an internationally accepted algorithm including a pre-test clinical probability (PTP according to the method of Wells et al.) and a high-sensitivity quantitative D-dimer assay. If the PTP is low and D-dimer negative, PE will be excluded. All other patients will undergo confirmatory diagnostic tests (either computerized tomography or ventilation/perfusion lung scanning) in order to confirm or rule out the presence of PE.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •first episode of syncope
排除标准
- •previous episodes of syncope
- •ongoing anticoagulation
- •age younger than 18 years
- •pregnancy
研究组 & 干预措施
First episode of loss of consciousness
干预措施: Lung CT or V/Q scanning in patients with a high pre-test clinical probability of PE and/or a positive D-dimer (Other)
结局指标
主要结局
To assess the prevalence of PE in a large series of consecutive patients presenting with the first episode of syncope
时间窗: Up to 48 hours after hospital admission
次要结局
- To assess the prevalence of pulmonary embolism in patients with apparently unexplained syncope(Up to one week after hospital admission)
研究者
Paolo Prandoni
Professor
University of Padova