SyncopeNCT05575934
Management of Transitory Loss of Consciousness and Syncopes in the Emergency Department
An observational study of Syncope and Unconscious State, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Syncope, Unconscious State
- How many people
- 250 participants
- Where
- 1 siteFrance
- Study dates
- 3 Oct 2022to 30 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- patients over 18 presenting to the Clermont-Ferrand University Hospital emergency department for transient loss of consciousness of syncopal or undifferentiated origin
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Clermont-Ferrand
Clermont-Ferrand, 63003
Lise Laclautre, promo_interne_drci@chu-clermontferrand.fr
Fares Moustafa, MD, PhD
About this study
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
Read the detailed description
Patients over the age of 18 presenting to the University Hospital of Clermont-Ferrand emergency department for transient loss of consciousness of syncopal or undifferentiated origin will be include. Their non-opposition will be sought.
Demographic, clinical, paraclinical and biological data will be collected from the emergency medical file.
No visit is planned after the passage to the emergency room.
- Conditions
- Syncope, Unconscious State
- Keywords
- transient loss of consciousness, syncope, emergency department
- Medical subject headings
- Syncope, Unconsciousness, Emergencies
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of transient loss of consciousness in emergency department
Percentage of TLOC in emergency department
Measured: 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
Measured: through the study duration, an average of 6 months
Secondary outcomes (2)
prevalence of different clinical presentations of loss of consciousness
Percentage of different clinical presentations of loss of consciousness
Measured: 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
Percentage of the various diagnostic tests carried out and the treatment of patients presenting for transient loss of consciousness
Measured: through the study duration, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2022
- Study start3 Oct 2022
- Primary completion25 Mar 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SyncopeStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fares Moustafa, MD, PhD, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05575934
- Sponsor's protocol ID
- EI22MG0908
- Status last verified
- Oct 2022
- First submitted
- 4 Oct 2022
- Last updated
- 12 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Transitory Loss of Consciousness and Syncopes in the Emergency Department
- ClinicalTrials.gov ID
- NCT05575934
- Acronym / sponsor ID
- EI22MG0908
- Conditions
- Syncope, Unconscious State
- Keywords
- transient loss of consciousness, syncope, emergency department
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 3 Oct 2022 (actual)
- Primary completion
- 25 Mar 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 12 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Patients over the age of 18 presenting to the University Hospital of Clermont-Ferrand emergency department for transient loss of consciousness of syncopal or undifferentiated origin will be include. Their non-opposition will be sought.
Demographic, clinical, paraclinical and biological data will be collected from the emergency medical file.
No visit is planned after the passage to the emergency room.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- patients over 18 presenting to the Clermont-Ferrand University Hospital emergency department for transient loss of consciousness of syncopal or undifferentiated origin
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
prevalence of transient loss of consciousness in emergency department
Time frame: through the study duration, an average of 6 months
Percentage of TLOC in emergency department
prevalence of different diagnoses leading to transient loss of consciousness
Time frame: through the study duration, an average of 6 months
Percentage of different diagnoses leading to transient loss of consciousness
2 secondary outcomes
prevalence of different clinical presentations of loss of consciousness
Time frame: 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
Time frame: through the study duration, an average of 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fares Moustafa, MD, PhD principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Syncope and Unconscious State, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lise Laclautre (334.73.754.963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of transient loss of consciousness in emergency department (time frame: through the study duration, an average of 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2022.