SyncopeSEEDNCT05571254
The Management of Transient Loss of Consciousness and Suspected Syncope in European Emergency Departments
An observational study of Syncope, run by NHS Lothian at 57 sites in 18 countries.
Trial summary
Prospective multi centre cohort study examining the clinical presentation, diagnostic tests, and management of adult Emergency Department (ED) patients presenting with Transient Loss of Consciousness (TLOC) either undifferentiated or thought to be of syncopal origin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Syncope
- What is being tested?
- Data collection
- How many people
- 952 participants
- Where
- 57 sitesin 18 countries
- Study dates
- 12 Sep 2022to 2 Dec 2022
- 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: Adults 18 years of age and older presenting to the ED over a two-week period with TLOC, either undifferentiated or thought to be of syncopal origin.
Who may be able to join
- Adult patients (≥18 years old) assessed in the ED with TLOC thought to be of syncopal origin.
Who cannot join
- Inability to consent
- Patient in custody or prison
- Aged <18 years
- TLOC thought to be due to neurological seizure (e.g., epilepsy/alcohol or drug withdrawal) or trauma
Trial locations and contacts
57 sites in 18 countries.
57 sites in 18 countries
Albania5 sites
Regional Hospital Durres
Durrës
Regional Hospital Centre "Xh. Kongoli" Elbasan
Elbasan
Spitali "Petro Nako" Sarandra
Sarandë
Regional Hospital Shkoder
Shkoder
University Hospital Centre "Mother Theresa" Tirana
Tirana
Denmark5 sites
Regionshospitalet Gødstrup
Herning
Nordsjællands Hospital
Hillerød
Regionshospitalet Randers
Randers
Sjællands Universitetshospital
Roskilde
Regionshospitalet Midt
Vildbjerg
France5 sites
CHU Besançon
Besançon
CHU Caen
Caen
CHU Clermond-Ferrand
Clermont-Ferrand
Medipole
Lyon
CHU Tours
Tours
Italy5 sites
ED Azienda Ospedaliera Universitaria di Bologna (Sant'Orsola Hospital)
Bologna
ED Azienda Ospedaliera-universitaria di Catania (San Marco Hospital)
Catania
ED Azienda USL Toscana Centro, Firenze (San Giovanni di Dio Hospital)
Florence
Azienda Ospedaliera di Perugia (Santa Maria Della Misericordia Hospital)
Perugia
ED Azienda Ospedaliera-Universitaria integrata (Borgo Trento Hospital)
Verona
Spain5 sites
Hospital Dr. Balmis
Alicante
Hospital clinic Barcelona
Barcelona
Hospital de Terrassa
Barcelona
Hospital Universitari de Bellvitge
Barcelona
Hospital Universitari de Vic
Barcelona
Turkey (Türkiye)5 sites
Gazi University Medical Faculty Department of Emergency Medicine
Ankara
Medical Science University Ankara Education and Research Hospital Department of Emergency Medicine
Ankara
Karamanoglu Mehmetbey University Karaman Education and Research Hospital Department of Emergency Medicine
Karaman
Necmettin Erbakan University Medical Faculty Department of Emergency Medicine
Konya
Medical Science University Sanliurfa Mehmet Akif Inan Education and Research Hospital Department of Emergency Medicine
Sanliurfa
United Kingdom5 sites
University Hospital Coventry & Warwickshire
Coventry
Royal Infirmary of Edinburgh
Edinburgh, Midlothian, EH16 4SA
Victoria Hospital
Kirkcaldy
St Johns Hospital, Livingston
Livingston
Royal Preston Hospital
Preston
Belgium4 sites
AZ Sint Jan Brugge
Bruges
AZ Alma Eeklo
Eeklo
Ghent University Hospital
Ghent
Heilig Hartziekenhuis Lier
Lier
Greece3 sites
University General Hospital ATTIKON
Athens
General Hospital Venizeleio
Heraklion
AHEPA Univesrity General Hospital of Thessaloniki
Thessaloniki
Serbia3 sites
Emergency Center Belgrade, Clinical Centre Belgade
Belgrade
Clinical Centre of Niš
Niš
Emergency Department Zaječar, Health Center Zaječar
Zaječar
Austria2 sites
Allgemeines Krankenhaus der Stadt Wien/ Universitätskliniken
Vienna
Klinik Donaustadt
Vienna
Czechia2 sites
University Hospital Hradec Králové
Králová
University Hospital Královské Vinohrady
Prague
Romania2 sites
Cluj Napoca County Emergency Clinical Hospital
Cluj-Napoca
Saint Spiridon County Hospital
Iași
About this study
Official title: The Management of Transient Loss of Consciousness (TLOC) and Suspected Syncope in European Emergency Departments: a Prospective Cohort Study
Prospective multi centre cohort study examining the clinical presentation, diagnostic tests, and management of adult Emergency Department (ED) patients presenting with Transient Loss of Consciousness (TLOC) either undifferentiated or thought to be of syncopal origin.
Read the detailed description
Syncope is a common ED problem. The three underlying causes are reflex (simple faint), orthostatic hypotension (blood pressure fall on standing) and cardiac disease (structural heart disease or cardiac dysrhythmia). Diagnosis is difficult and is not apparent in ~50% of patients after assessment. For the first time, European Society of Cardiology (ESC) guidelines incorporating ED management of patients presenting with TLOC, either undifferentiated or thought to be of syncopal origin, have been produced.
However, very little is currently known about the use of diagnostic algorithms and management of this patient group in EDs across Europe. As a result, the application of guidelines and the management of TLOC by European Society of Emergency Medicine (EUSEM) members in different countries and hospitals, cannot yet be recommended for use in settings other than those where they have been successfully validated.
This study aims to describe the prevalence, clinical presentation, current assessment, management strategies and ESC risk categories of patients presenting with TLOC (undifferentiated or thought to be of syncopal origin) to the ED, and will provide data to help identify the gaps in our knowledge and practice, and areas where further research and development work is required to fully implement European Society of Cardiology (ESC) guidelines within European EDs.
- Conditions
- Syncope
- Being tested
- Data collection
- Keywords
- syncope, transient loss of consciousness, emergency department
- Medical subject headings
- Syncope, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
All patients will have a focussed Case Report Form completed collecting routine data describing the prevalence, clinical presentation, assessment, management and ESC risk category of patients, at the time or shortly after the patients ED attendance.
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant age
Participant age
Measured: Admission
Participant gender
Participant gender
Measured: Admission
Mode of arrival
Mode of arrival
Measured: Admission
Referral source
Referral source
Measured: Admission
Presence of any European Society of Cardiology (ESC) syncope high-risk history features
Which European Society of Cardiology syncope high-risk history features are present
Measured: Admission
ESC high-risk 'past medical history' features
Which European Society of Cardiology syncope high-risk 'past medical history' features are present
Measured: Admission
Other medical comorbidities
Other medical comorbidities
Measured: Admission
Rockwood Clinical Frailty Scale score
Rockwood Clinical Frailty Scale is a well validated score ranging from 1 (Very Fit) to 9 (Terminally Ill) with defined descriptions for each category.
Measured: Admission
ESC high risk 'physical examination' factors
ESC high risk 'physical examination' factors
Measured: Admission
Blood pressure (BP) on admission
First Blood pressure (BP) measure in the Emergency Department in mmHg
Measured: Admission
Pulse rate on admission
First pulse rate measured in the Emergency Department in beats per minute
Measured: Admission
Lying/standing systolic BP difference on admission
First lying/standing systolic BP difference measured in the Emergency Department in mmHg
Measured: Admission
Number of participants with abnormal Electrocardiogram (ECG) readings
Number of participants with abnormal ECG readings
Measured: Admission
Troponin levels
Troponin levels
Measured: Admission
D-dimer levels
D-dimer levels
Measured: Admission
Copeptin levels
Copeptin levels
Measured: Admission
Natriuretic peptides levels
Natriuretic peptides levels
Measured: Admission
ED clinician diagnosis
ED clinician diagnosis - descriptive
Measured: Admission
Patient destination
Descriptive options: Admitted to Observation/Clinical Decision Unit/Same Day Emergency Care unit/hospital floor with telemetry monitoring/hospital floor with no telemetry monitoring. Discharged to outpatient follow up/family doctor/General Practitioner care/home with no follow up
Measured: Admission
Reason(s) for admission
Reason(s) for admission
Measured: Admission
Whether driving and occupation advice given
Whether driving and occupation advice given
Measured: Admission
Status at discharge from hospital
Status at discharge from hospital
Measured: 30 days
Length of hospital stay in days
Length of hospital stay in days
Measured: 30 days
Hospital discharge diagnosis
Hospital discharge diagnosis
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2022
- Study start12 Sep 2022
- Primary completion2 Dec 2022
- Study completion2 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SyncopeStudies of the same condition, open and under way.
- 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
- 952 participants (actual)
Sponsor and investigators
- Lead sponsor
- NHS Lothian
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Matt Reed, Study chair, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05571254
- Sponsor's protocol ID
- AC22033
- Acronym
- SEED
- Status last verified
- Sep 2022
- First submitted
- 26 Sep 2022
- Last updated
- 23 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Vaittinada Ayar P, Kearns D, Vaittinada Ayar P, Laribi S. Effect of sex on syncope management in European emergency departments: the European Society for Emergency Medicine Research network Syncope in European Emergency Departments study. Eur J Emerg Med. 2026 Jun 1;33(3):197-202. doi: 10.1097/MEJ.0000000000001294. Epub 2026 Apr 27. No abstract available.
PubMed 42053083Reed MJ, Karuranga S, Kearns D, Alawiye S, Clarke B, Mockel M, Karamercan M, Janssens K, Riesgo LG, Torrecilla FM, Golea A, Fernandez Cejas JA, Lupan-Muresan EM, Zaimi E, Nuernberger A, Rennet O, Skjaerbaek C, Polyzogopoulou E, Imecz J, Groff P, Camilleri R, Cimpoesu D, Jovic M, Miro O, Anderson R, Laribi S; SEED investigators. Management of syncope in the Emergency Department: a European prospective cohort study (SEED). Eur J Emerg Med. 2024 Apr 1;31(2):136-146. doi: 10.1097/MEJ.0000000000001101. Epub 2023 Nov 27.
PubMed 38015745
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Management of Transient Loss of Consciousness (TLOC) and Suspected Syncope in European Emergency Departments: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05571254
- Acronym / sponsor ID
- SEED / AC22033
- Conditions
- Syncope
- Keywords
- syncope, transient loss of consciousness, emergency department
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 952 participants (actual)
- Lead sponsor
- NHS LothianOther government
- Study start
- 12 Sep 2022 (actual)
- Primary completion
- 2 Dec 2022 (actual)
- Study completion
- 2 Dec 2022 (actual)
- First posted
- 7 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.
Prospective multi centre cohort study examining the clinical presentation, diagnostic tests, and management of adult Emergency Department (ED) patients presenting with Transient Loss of Consciousness (TLOC) either undifferentiated or thought to be of syncopal origin.
Detailed description
Syncope is a common ED problem. The three underlying causes are reflex (simple faint), orthostatic hypotension (blood pressure fall on standing) and cardiac disease (structural heart disease or cardiac dysrhythmia). Diagnosis is difficult and is not apparent in ~50% of patients after assessment. For the first time, European Society of Cardiology (ESC) guidelines incorporating ED management of patients presenting with TLOC, either undifferentiated or thought to be of syncopal origin, have been produced.
However, very little is currently known about the use of diagnostic algorithms and management of this patient group in EDs across Europe. As a result, the application of guidelines and the management of TLOC by European Society of Emergency Medicine (EUSEM) members in different countries and hospitals, cannot yet be recommended for use in settings other than those where they have been successfully validated.
This study aims to describe the prevalence, clinical presentation, current assessment, management strategies and ESC risk categories of patients presenting with TLOC (undifferentiated or thought to be of syncopal origin) to the ED, and will provide data to help identify the gaps in our knowledge and practice, and areas where further research and development work is required to fully implement European Society of Cardiology (ESC) guidelines within European EDs.
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
- Adults 18 years of age and older presenting to the ED over a two-week period with TLOC, either undifferentiated or thought to be of syncopal origin.
Key inclusion criteria (1 listed)
- Adult patients (≥18 years old) assessed in the ED with TLOC thought to be of syncopal origin.
Key exclusion criteria (4 listed)
- Inability to consent
- Patient in custody or prison
- Aged <18 years
- TLOC thought to be due to neurological seizure (e.g., epilepsy/alcohol or drug withdrawal) or trauma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data collectionAll patients will have a focussed Case Report Form completed collecting routine data describing the prevalence, clinical presentation, assessment, management and ESC risk category of patients, at the time or shortly after the patients ED attendance. | Other | – |
Primary outcome
Participant age
Time frame: Admission
Participant age
Participant gender
Time frame: Admission
Participant gender
Mode of arrival
Time frame: Admission
Mode of arrival
Referral source
Time frame: Admission
Referral source
Presence of any European Society of Cardiology (ESC) syncope high-risk history features
Time frame: Admission
Which European Society of Cardiology syncope high-risk history features are present
ESC high-risk 'past medical history' features
Time frame: Admission
Which European Society of Cardiology syncope high-risk 'past medical history' features are present
Other medical comorbidities
Time frame: Admission
Other medical comorbidities
Rockwood Clinical Frailty Scale score
Time frame: Admission
Rockwood Clinical Frailty Scale is a well validated score ranging from 1 (Very Fit) to 9 (Terminally Ill) with defined descriptions for each category.
ESC high risk 'physical examination' factors
Time frame: Admission
ESC high risk 'physical examination' factors
Blood pressure (BP) on admission
Time frame: Admission
First Blood pressure (BP) measure in the Emergency Department in mmHg
Pulse rate on admission
Time frame: Admission
First pulse rate measured in the Emergency Department in beats per minute
Lying/standing systolic BP difference on admission
Time frame: Admission
First lying/standing systolic BP difference measured in the Emergency Department in mmHg
Number of participants with abnormal Electrocardiogram (ECG) readings
Time frame: Admission
Number of participants with abnormal ECG readings
Troponin levels
Time frame: Admission
Troponin levels
D-dimer levels
Time frame: Admission
D-dimer levels
Copeptin levels
Time frame: Admission
Copeptin levels
Natriuretic peptides levels
Time frame: Admission
Natriuretic peptides levels
ED clinician diagnosis
Time frame: Admission
ED clinician diagnosis - descriptive
Patient destination
Time frame: Admission
Descriptive options: Admitted to Observation/Clinical Decision Unit/Same Day Emergency Care unit/hospital floor with telemetry monitoring/hospital floor with no telemetry monitoring. Discharged to outpatient follow up/family doctor/General Practitioner care/home with no follow up
Reason(s) for admission
Time frame: Admission
Reason(s) for admission
Whether driving and occupation advice given
Time frame: Admission
Whether driving and occupation advice given
Status at discharge from hospital
Time frame: 30 days
Status at discharge from hospital
Length of hospital stay in days
Time frame: 30 days
Length of hospital stay in days
Hospital discharge diagnosis
Time frame: 30 days
Hospital discharge diagnosis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.
- Derived from this study: PubMed 42053083Vaittinada Ayar P, Kearns D, Vaittinada Ayar P, Laribi S. Effect of sex on syncope management in European emergency departments: the European Society for Emergency Medicine Research network Syncope in European Emergency Departments study. Eur J Emerg Med. 2026 Jun 1;33(3):197-202. doi: 10.1097/MEJ.0000000000001294. Epub 2026 Apr 27. No abstract available.
- Derived from this study: PubMed 38015745Reed MJ, Karuranga S, Kearns D, Alawiye S, Clarke B, Mockel M, Karamercan M, Janssens K, Riesgo LG, Torrecilla FM, Golea A, Fernandez Cejas JA, Lupan-Muresan EM, Zaimi E, Nuernberger A, Rennet O, Skjaerbaek C, Polyzogopoulou E, Imecz J, Groff P, Camilleri R, Cimpoesu D, Jovic M, Miro O, Anderson R, Laribi S; SEED investigators. Management of syncope in the Emergency Department: a European prospective cohort study (SEED). Eur J Emerg Med. 2024 Apr 1;31(2):136-146. doi: 10.1097/MEJ.0000000000001101. Epub 2023 Nov 27.
- Individual participant dataSharing planned: Undecided
Related trials for Syncope
RecruitingObservational study
Genetic Markers of Cardiovascular Disease in Epilepsy
Epilepsy, Seizures
RecruitingObservational study
Whole-Body Point-of-Care Ultrasound in Older Adults Presenting to the Emergency Department After a Fall
Accidental Falls, Aged
Not yet recruiting
Head-to-Head (H2H) Comparison of Ambulatory Cardiac ECG Monitors in Japan
Atrial Fibrillation (AF), Atrial Flutter
RecruitingObservational study
Fainting Detection And Early Warning In Syncope Evaluation Study (ARISE)
Orthostatic Hypotension, Reflex Syncope
Active, not recruiting
Cardioneuroablation for Reflex Syncope and Exercise Capacity
Syncope, Vasovagal
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.
Matt Reed study chair
University of Edinburgh
57 sites in 18 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Syncope, run by NHS Lothian at 57 sites in 18 countries.
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 4 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: finished, as of the sponsor's last update on 23 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 57 sites in Albania, Denmark, France, Italy, Spain and 13 more countries. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant age (time frame: Admission). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05571254, which also lists 2 linked publications.
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 23 Mar 2023.