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Prevalence of PE in ED Patients With Isolated Syncope

NCT ID: NCT03487237

Last Updated: 2018-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

459 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-23

Study Completion Date

2018-12-18

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

Conditions

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Syncope

Keywords

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Syncope Pulmonary embolism emergency department clinical decision rule

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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All patient

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.

Group Type EXPERIMENTAL

Ddimer testing

Intervention Type 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.

Interventions

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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.

Intervention Type BIOLOGICAL

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pierre-Alexis Raynal, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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Hôpital Saint Antoine

Paris, , France

Site Status

Countries

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France

Other Identifiers

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K171102J

Identifier Type: -

Identifier Source: org_study_id