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临床试验/NCT03487237
NCT03487237已完成不适用

Prevalence of Pulmonary Embolism in Emergency Department Patients With Isolated Syncope

Assistance Publique - Hôpitaux de Paris2 个研究点 分布在 1 个国家目标入组 459 人开始时间: 2018年5月23日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
459
试验地点
2
主要终点
diagnosis of Pulmonary embolism within 72 hrs after ED visit Safety

研究概览

简要总结

Syncope is a rapid onset, transient, loss of consciousness with a short duration. This symptom has been reported to be a specific presentation of patients with pulmonary embolism. However, the prevalence of pulmonary embolism in patients with syncope remains debated. This prospective cohort study will recruit patients presenting to the emergency department with a syncope, who will systematically undergo formal workup for pulmonary embolism. The main objective of this study is to assess the prevalence of pulmonary embolism in ED patients with syncope

详细描述

Syncope is a rapid onset, transient, loss of consciousness with a short duration. This symptom has been reported to be a specific presentation of patients with pulmonary embolism. However, the prevalence of pulmonary embolism in patients with syncope remains debated. This prospective cohort study will recruit patients presenting to the emergency department with a syncope, who will systematically undergo formal workup for pulmonary embolism. The main objective of this study is to assess the prevalence of pulmonary embolism in ED patients with syncope

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

入选标准

  • Age >= 18 years visiting the Emergency Department,
  • history of syncope in the past 24 hours: loss of consciousness, rapid onset, short duration (<1 min), transient, with spontaneous and rapid recovery without post event confusion
  • With or without prodromes
  • Without any other obvious cause
  • Informed written consent
  • Affiliation to a social security system (AME Excepted)

排除标准

  • Other criteria for PE suspicion : Acute onset of dyspnea Acute severe chest pain,
  • Pregnancy
  • Concurrent anticoagulation treatment
  • Other obvious cause of syncope : Seizure, Stroke, Traumatic brain injury , toxic intake , Atrioventricular block type 3

研究组 & 干预措施

All patient

Experimental

Included patients will undergo a formal work up for pulmonary embolism: Ddimer testing, followed if positive by a computed tomography pulmonary angiogram or V/Q scan.

干预措施: Ddimer testing (Biological)

结局指标

主要结局

diagnosis of Pulmonary embolism within 72 hrs after ED visit Safety

时间窗: 72 hours after ED visit

diagnosis of Pulmonary embolism within 72 hrs after ED visit ( Ddimer testing, followed if positive by a computed tomography pulmonary angiogram or V/Q scan).

次要结局

  • Validation of usual clinical decision rules-Wells(Day 0)
  • Validation of usual clinical decision rules-Revised Geneva Score(Day 0)
  • Validation of usual clinical decision rules-PERC(Day 0)
  • Prevalence of Pulmonary Embolism among patients with cancer history.(Day 28)
  • rate of false positive of the PERC rule(72 hours after ED visit)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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