Prevalence of PE in ED Patients With Isolated Syncope

NCT03487237 | Completed

• 1 other identifier: K171102J
• Study Type: interventional
• Target: 459
• Locations: 1 country
• Sites: 1

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

Conditions

Syncope

Keywords

Syncope; Pulmonary embolism; emergency department; clinical decision rule

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Validation of usual clinical decision rules-Wells

  Day 0

• Validation of usual clinical decision rules-Revised Geneva Score

  Day 0

• Validation of usual clinical decision rules-PERC

  Day 0

• Prevalence of Pulmonary Embolism among patients with cancer history.

  Day 28

• rate of false positive of the PERC rule

  72 hours after ED visit

Study Arms (1)

All patient

EXPERIMENTAL

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.

Biological: Ddimer testing

Interventions

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.

All patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Saint Antoine

Paris, 75012, France

Location

MeSH Terms

Conditions

Syncope; Pulmonary Embolism; Emergencies

Condition Hierarchy (Ancestors)

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

Study Officials

• Pierre-Alexis Raynal, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2018
• First Posted: April 3, 2018
• Study Start: May 23, 2018
• Primary Completion: December 18, 2018
• Study Completion: December 18, 2018
• Last Updated: December 27, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)