Prevalence of PE in ED Patients With Isolated Syncope

Assistance Publique - Hôpitaux de Paris459 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

459

Conditions

Syncope

Interventions

Ddimer testingBIOLOGICAL

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Hôpital Saint Antoine

Paris, France

Outcomes

Primary Outcomes

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).

Time frame: 72 hours after ED visit

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: Day 0

Prevalence of Pulmonary Embolism among patients with cancer history.

Time frame: Day 28

rate of false positive of the PERC rule

Patients with a PERC=0 ultimately diagnosed with a pulmonary embolism within 72 hours

Data from ClinicalTrials.gov

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