Clinical trial NCT03487237: Prevalence of PE in ED Patients With Isolated Syncope
Official title: Prevalence of Pulmonary Embolism in Emergency Department Patients With Isolated Syncope
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Syncope
Keywords: Syncope
Pulmonary embolism
emergency department
clinical decision rule
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2018-04-03
Enrollment: 459
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

- 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

Primary outcomes:
measure: diagnosis of Pulmonary embolism within 72 hrs after ED visit Safety
timeFrame: 72 hours after ED visit
Secondary outcomes:
measure: Validation of usual clinical decision rules-Wells
timeFrame: Day 0
measure: Validation of usual clinical decision rules-Revised Geneva Score
timeFrame: Day 0
measure: Validation of usual clinical decision rules-PERC
timeFrame: Day 0
measure: Prevalence of Pulmonary Embolism among patients with cancer history.
timeFrame: Day 28
measure: rate of false positive of the PERC rule
timeFrame: 72 hours after ED visit
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Saint Antoine
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Pierre-Alexis Raynal, MD
role: PRINCIPAL_INVESTIGATOR
References: