Prevalence of PE in ED Patients With Isolated Syncope

Study Overview
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Brief Summary
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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
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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

Official Title
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Prevalence of Pulmonary Embolism in Emergency Department Patients With Isolated Syncope

Conditions
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Syncope

Intervention / Treatment
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* Biological: Ddimer testing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: All patient<br>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. | Biological: Ddimer testing<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diagnosis of Pulmonary embolism within 72 hrs after ED visit Safety | 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). | 72 hours after ED visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validation of usual clinical decision rules-Wells | 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 | Day 0 | 
| Validation of usual clinical decision rules-Revised Geneva Score | 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 | Day 0 | 
| Validation of usual clinical decision rules-PERC | 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 | Day 0 | 
| Prevalence of Pulmonary Embolism among patients with cancer history. |  | Day 28 | 
| rate of false positive of the PERC rule | Patients with a PERC=0 ultimately diagnosed with a pulmonary embolism within 72 hours | 72 hours after ED visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Syncope, Pulmonary embolism, emergency department, clinical decision rule