An observational study in Syncope, sponsored by NHS Lothian. Completed at 57 sites in 18 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-23.
Sponsored by NHS Lothian · Observational
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.
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.
201 studies on the registry are indexed under Syncope; 36 are open to participants now.
This study's enrollment of 952 is above the median of 250 across 84 observational studies indexed under Syncope.
Browse Syncope studies →NHS Lothian is the lead sponsor of 53 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Participant age
Participant age
Time frame: Admission
Participant gender
Participant gender
Time frame: Admission
Mode of arrival
Mode of arrival
Time frame: Admission
Referral source
Referral source
Time frame: 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
Time frame: Admission
ESC high-risk 'past medical history' features
Which European Society of Cardiology syncope high-risk 'past medical history' features are present
Time frame: Admission
Other medical comorbidities
Other medical comorbidities
Time frame: 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.
Time frame: Admission
ESC high risk 'physical examination' factors
ESC high risk 'physical examination' factors
Time frame: Admission
Blood pressure (BP) on admission
First Blood pressure (BP) measure in the Emergency Department in mmHg
Time frame: Admission
Pulse rate on admission
First pulse rate measured in the Emergency Department in beats per minute
Time frame: Admission
Lying/standing systolic BP difference on admission
First lying/standing systolic BP difference measured in the Emergency Department in mmHg
Time frame: Admission
Number of participants with abnormal Electrocardiogram (ECG) readings
Number of participants with abnormal ECG readings
Time frame: Admission
Troponin levels
Troponin levels
Time frame: Admission
D-dimer levels
D-dimer levels
Time frame: Admission
Copeptin levels
Copeptin levels
Time frame: Admission
Natriuretic peptides levels
Natriuretic peptides levels
Time frame: Admission
ED clinician diagnosis
ED clinician diagnosis - descriptive
Time frame: 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
Time frame: Admission
Reason(s) for admission
Reason(s) for admission
Time frame: Admission
Whether driving and occupation advice given
Whether driving and occupation advice given
Time frame: Admission
Status at discharge from hospital
Status at discharge from hospital
Time frame: 30 days
Length of hospital stay in days
Length of hospital stay in days
Time frame: 30 days
Hospital discharge diagnosis
Hospital discharge diagnosis
Time frame: 30 days
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
NHS Lothian