Prevalence of PE in ED Patients With Isolated Syncope

Syncope Clinical Trial

— PEEPS  

Official title:

Prevalence of Pulmonary Embolism in Emergency Department Patients With Isolated Syncope

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03487237
• Other study ID #: K171102J
• Status: Completed
• Phase: N/A
• Start date: May 23, 2018
• Est. completion date: December 18, 2018

Study information

• Verified date: December 2018
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 459
• Est. completion date: December 18, 2018
• Est. primary completion date: December 18, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pulmonary Embolism
• Syncope

Intervention

Biological:
• 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.

Locations

Country	Name	City	State
France	Hôpital Saint Antoine	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Prevalence of Pulmonary Embolism among patients with cancer history.		Day 28
Secondary	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