Skip to main content
OpenTrials
Completed

NCT Number: NCT03487237

Prevalence of PE in ED Patients With Isolated Syncope

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Syncope Cardiovascular Diseases Consciousness Disorders Disease Attributes Embolism Embolism and Thrombosis Emergencies Lung Diseases Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Embolism Respiratory Tract Diseases Signs and Symptoms Unconsciousness Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Saint Antoine

Paris, 75012, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ddimer testing

Biological

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 outcomes

  1. diagnosis of Pulmonary embolism within 72 hrs after ED visit Safety

    Time frame: 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 outcomes

  1. Validation of usual clinical decision rules-Wells

    Time frame: 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

  2. Validation of usual clinical decision rules-Revised Geneva Score

    Time frame: 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

  3. Validation of usual clinical decision rules-PERC

    Time frame: 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

  4. Prevalence of Pulmonary Embolism among patients with cancer history.

    Time frame: Day 28

  5. rate of false positive of the PERC rule

    Time frame: 72 hours after ED visit

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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Prevalence of Pulmonary Embolism in Emergency Department Patients With Isolated Syncope

Acronym: PEEPS

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Apr 3, 2018
Registry last updated
Dec 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.