NCT05575934

Brief Summary

The goal of this observational study is to examine the clinical presentations, the diagnostic tests performed and the management of patients presenting with transient loss of consciousness (TLOC) The main questions it aims to answer are:

  • prevalence of TLOC
  • prevalence of different diagnoses leading to TLOC Demographic, clinical, paraclinical and biological data will be collected from the emergency medical file

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 3, 2022

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

October 4, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 12, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

October 12, 2022

Status Verified

October 1, 2022

Enrollment Period

6 months

First QC Date

October 4, 2022

Last Update Submit

October 7, 2022

Conditions

Keywords

transient loss of consciousnesssyncopeemergency department

Outcome Measures

Primary Outcomes (2)

  • prevalence of transient loss of consciousness in emergency department

    Percentage of TLOC in emergency department

    through the study duration, an average of 6 months

  • prevalence of different diagnoses leading to transient loss of consciousness

    Percentage of different diagnoses leading to transient loss of consciousness

    through the study duration, an average of 6 months

Secondary Outcomes (2)

  • prevalence of different clinical presentations of loss of consciousness

    through the study duration, an average of 6 months

  • Prevalence of the various diagnostic tests carried out and the treatment of patients presenting for transient loss of consciousness

    through the study duration, an average of 6 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All adult patients presenting to the emergency room of the CHU de Clermont-Ferrand with a transient loss of consciousness of syncopal or undifferentiated origin will be included once the non-objection has been collected.

You may qualify if:

  • patients over 18 presenting to the Clermont-Ferrand University Hospital emergency department for transient loss of consciousness of syncopal or undifferentiated origin

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

MeSH Terms

Conditions

SyncopeUnconsciousnessEmergencies

Condition Hierarchy (Ancestors)

Consciousness DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsDisease AttributesPathologic Processes

Study Officials

  • Fares Moustafa, MD, PhD

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2022

First Posted

October 12, 2022

Study Start

October 3, 2022

Primary Completion

March 25, 2023

Study Completion

September 30, 2023

Last Updated

October 12, 2022

Record last verified: 2022-10

Locations