Prevalence of Pulmonary Embolism (PE) Among Patients Referred to Emergency Departments for Dyspnea on Exertion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Prevalence of PE in the overall population
研究概览
简要总结
PEDIS Study is an observational, cross-sectional, multicenter Italian study conducted in a consecutive series of patients who refer to the Emergency Departments (either spontaneously or sent by their attending physicians) for the recent (less than one months) development of exertional dyspnea.
The general aim of the study is to assess the prevalence of PE in the overall population referring to the Emergency Departments without potential explanations for dyspnea
详细描述
PEDIS Study is an observational, cross-sectional, multicenter and no Profit Study.
600 consecutive patients referring to the Emergency Departments of the participating centers because they have developed one or more episodes of exertional dyspnea since less than one month will be enrolled. All eligible patients will be interviewed and examined by trained study physicians. The presence of already known potential explanations for the dyspnea will be assessed. In addition, symptoms of the lower extremities will be elicited, as well as the presence of risk factors for venous thromboembolism (VTE).
The presence or absence of pulmonary embolism will be assessed with the use of a validated algorithm based on pre-test clinical probability and D-dimer result. In patients in whom the pre-test clinical probability is low and the D-dimer result is negative, no further testing will be done, and PE will be considered excluded. In patients with high clinical probability, positive D-dimer result, or both, computed tomography (CT) pulmonary angiography will be performed
The primary study objective is to evaluate Prevalence of PE in the overall population
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age older than 18 and younger than 75
- •Recent (less than one month) development of exertional dyspnea
- •Able to provide informed consent
排除标准
- •Anticoagulation required for other indications
- •Contraindication to CT angiography (allergy to the contrast dye, severe renal failure [creatinine clearance < 30 ml/min])
- •Involvement in simultaneous clinical trials
- •Unable to provide their written informed consent
结局指标
主要结局
Prevalence of PE in the overall population
时间窗: From the first day of enrollment up to 104 weeks
Prevalence of Pulmonary Embolism in patient with high pre-test clinical probability and/or positive D-dimer without potential explanations for the dyspnea who underwent computed tomography pulmonary angiography
次要结局
未报告次要终点