Prevalence of PE in ED Patients With Isolated Syncope

Not Applicable

Completed

• Conditions: Syncope
• Interventions: Biological: Ddimer testing

• Registration Number: NCT03487237
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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

Study Timeline

• Study First Submitted: 2018-03-01
• Study First Submitted QC: 2018-03-27
• Study First Posted: 2018-04-03
• Study Start: 2018-05-23
• Status Verified: 2018-12
• Primary Completion: 2018-12-18
• Study Completion: 2018-12-18
• Last Update Submitted: 2018-12-26
• Last Update Posted: 2018-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 459

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All patient	Ddimer testing	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.

Primary Outcome Measures

Name	Time	Method
diagnosis of Pulmonary embolism within 72 hrs after ED visit Safety	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).

Secondary Outcome Measures

Name	Time	Method
Validation of usual clinical decision rules-Wells	Day 0	Wells score: Clinical signs and symptoms of DVT 3 Immobilization or surgery within 4 weeks 1.5 Heart rate \> 100 beats per min 1.5 Previous DVT or PE 1.5 Hemoptysis 1 Malignancy 1 Alternative diagnosis is less likely than PE 3 Low: 0-1; intermediate: 2-6; high: \>6
Validation of usual clinical decision rules-Revised Geneva Score	Day 0	Age \> 65 years 1 Previous DVT or PE 3 Surgery or fracture within 1 monht 2 Active malignant condition within a year 2 Unilateral lower limb pain 3 Hemoptysis 2 Heart Rate 75 - 94 beats per min 3 \>94 beats per min 5 Pain on lower limb deep venous palpation and unilateral edema 5 low: 0-3; intermediate: 4-10; high: \>11
Validation of usual clinical decision rules-PERC	Day 0	PERC: * Age less than 50 years; * Heart rate less than 100 beats per minute; * No prior history of thrombo-embolic event; * Oxygen saturation greater than 94%; * No trauma or surgery in the past four weeks; * No hemoptysis; * No exogenous estrogen intake; * No unilateral leg swelling
Prevalence of Pulmonary Embolism among patients with cancer history.	Day 28
rate of false positive of the PERC rule	72 hours after ED visit	Patients with a PERC=0 ultimately diagnosed with a pulmonary embolism within 72 hours

Trial Locations

Locations (1)

Hôpital Saint Antoine; 🇫🇷 Paris, France