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Prevalence of PE in ED Patients With Isolated Syncope (PEEPS)

Primary Purpose

Syncope

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Ddimer testing
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Syncope focused on measuring Syncope, Pulmonary embolism, emergency department, clinical decision rule

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital Saint Antoine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

All patient

Arm Description

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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
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
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
Prevalence of Pulmonary Embolism among patients with cancer history.
rate of false positive of the PERC rule
Patients with a PERC=0 ultimately diagnosed with a pulmonary embolism within 72 hours

Full Information

First Posted
March 1, 2018
Last Updated
December 26, 2018
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT03487237
Brief Title
Prevalence of PE in ED Patients With Isolated Syncope
Acronym
PEEPS
Official Title
Prevalence of Pulmonary Embolism in Emergency Department Patients With Isolated Syncope
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
May 23, 2018 (Actual)
Primary Completion Date
December 18, 2018 (Actual)
Study Completion Date
December 18, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Syncope
Keywords
Syncope, Pulmonary embolism, emergency department, clinical decision rule

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
459 (Actual)

8. Arms, Groups, and Interventions

Arm Title
All patient
Arm Type
Experimental
Arm Description
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
Intervention Name(s)
Ddimer testing
Intervention Description
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 Measure Information:
Title
diagnosis of Pulmonary embolism within 72 hrs after ED visit Safety
Description
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 Outcome Measure Information:
Title
Validation of usual clinical decision rules-Wells
Description
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
Title
Validation of usual clinical decision rules-Revised Geneva Score
Description
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
Title
Validation of usual clinical decision rules-PERC
Description
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
Title
Prevalence of Pulmonary Embolism among patients with cancer history.
Time Frame
Day 28
Title
rate of false positive of the PERC rule
Description
Patients with a PERC=0 ultimately diagnosed with a pulmonary embolism within 72 hours
Time Frame
72 hours after ED visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre-Alexis Raynal, MD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Saint Antoine
City
Paris
ZIP/Postal Code
75012
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Prevalence of PE in ED Patients With Isolated Syncope

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