An observational study in Syncope, sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). Recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-24.
Sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Observational
Syncope is very common and has a broad differential diagnosis. Guidelines on syncope recommend to apply guideline based syncope algorithm (SA) to identify low- / intermediate risk syncope patients and recommend to discharge these patients. The time window when to discharge these patients is not defined in the guidelines. In current medical practice low- / intermediate risk syncope patients are either immediately discharged or discharged after 24-hour observation with telemetry (TM). There seems to be an equipoise for both treatment strategies in current medical practice for these low risk syncope patients. A randomized controlled trial to compare discharge after 24 hour observation including TM with immediate discharge has never been done on the Cardiac Emergency Room (CER).
The diagnosis of syncope is a worldwide clinical dilemma. Appropriate identification of low risk vs high risk will reduce inappropriate admission for 24-hour observation with TM. The Dutch Geriatrics Society prioritized syncope management on its research agenda. This project is endorsed by the Dutch Societies of Neurology, Cardiology, Geriatrics, and Internal Medicine and results in freely accessible tutorials on an educational website: www.syncopedia.org.
A randomized clinical trial that includes guideline based SA as routine medical care in the setting of a cardiac emergency room, that compares discharge after 24-hour observation with TM (reference treatment strategy) and immediate discharge (investigational treatment strategy) for low- and intermediate syncope patients will provide new insights and improve syncope health care for these patients.
201 studies on the registry are indexed under Syncope; 36 are open to participants now.
This study's planned enrollment of 640 is above the median of 250 across 84 observational studies indexed under Syncope.
Browse Syncope studies →Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) is the lead sponsor of 532 studies on the registry; 183 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients attending the Cardiac Emergency Room with low- and intermediate risk syncope.
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.
All patients that are assessed as low- and intermediate risk syncope, are eligible for inclusion in this trial.
The initial syncope evaluation includes:
Exclusion Criteria:
A potential patient who meets any of the following criteria will be excluded from participation in this study:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
immediate discharge with ambulant HR monitoring (investigational treatment strategy) in low- and intermediate syncope patients in the setting of cardiac emergency room
Diagnostic Test: holter
discharge after 24-hour telemetric-observation (reference treatment strategy) in low- and intermediate syncope patients in the setting of cardiac emergency room
Diagnostic Test: holter
ambulant heart rate monitor (holter) for 24 hour.
Incidence of Supraventricular tachycardia:
a) Any atrial tachycardia (sustained or non-sustained ≥ 3 consecutive complexes) b) Atrio-Ventricular Nodal Re-entry Tachycardia (AVNRT) or Atrioventricular Re-Entry Tachycardia (AVRT) c) Premature Atrial Complex (PAC): \>2 doublets or \>2 episodes of 3 seconds duration of bi- or trigeminy d) Atrial Fibrillation de novo
Time frame: 24 hour after randomization
Incidence of Ventricular tachycardia:
a) Any Ventricular Tachycardia (sustained/non sustained) b) Ventricular Fibrillation c) Premature Ventricular Complexes: \>2 doublets or \>2 episodes of 3 seconds duration of bi- or trigemini
Time frame: 24 hour after randomization
Incidence of Conduction disorders:
a) Asystole \>3sec (including conversion pauses) b) New first degree AV block with PQ\>300 msec c) Progression first degree AV block with 15% c) 2nd degree AV block Mobitz type I and II d) 3rd degree AV block e) Any SA block
Time frame: 24 hour after randomization
Incidence of Other events
a) Syncope recurrence b) Unexplained fall with injury c) All cause death d) Cardiovascular death
Time frame: 24 hour after randomization
Comparison of Syncope related healthcare costs
Health care costs will be calculated on the basis of the tariffs set by the schedule of the Dutch National Health Service.
Time frame: 1 month
Hospital utilization and duration of total in-hospital stay for both arms
Hospital utilization of both treatment strategies will be quantified by the duration of the in-hospital stay from the moment of randomization.
Time frame: 1 month
Proportion of additional diagnoses after both treatment strategies
The analysis will be conducted at the major group level, i.e. (1) reflex syncope, (2) orthostatic hypotension, (3) cardiac syncope. Diagnostic yield is defined as the number of patients receiving a diagnosis in the patient chart and is determined at two times during this trial: 1. After performing the guideline based syncope algorithm (before enrollment of the patient) and 2. At 24 hours after completing each treatment strategy.
Time frame: 24 hour after randomization
Assessment of Quality of life (EQ5D - EuroQuol 5Dimensions)
The questionnaires include a check-list to assess health care consumption (consultations, admissions), productivity, and QoL measures. 5 dimensions for describing health states. Scores are: no, mild, moderate, severe and extreme or unable to do. (can be scored as 1-5) In the questionnaire is also an Visual Analogue Scale: overall assessment of respondent's health on a scale from 0 (worst health imaginable) to 100 (best health imaginable).
Time frame: up to 1 Month
Assessment of Quality of life (Short Form Health Survey 12)
Questionnaire to asses Quality of Life. Questionnaire contains closed questions with different response options. 'Yes/no', 'never(1)-always(6)' or 'no limitation(1)-severe limitation(3)'
Time frame: up to 1 Month
Assessment of Quality of life (SyncopeDailyFunctioning)
Questionnaire to assess qyality of life in daily functioning. Questionnaire contains closed questions with different response options. 'Yes/no' or '1(negative)-8(positive)'
Time frame: up to 1 Month
Started Nov 2023 (actual). Primary completion is estimated for Aug 2026, 32 months after the start.
Of 44 observational studies under Syncope, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 13. This study's planned 32 months is close to that.
How these figures are worked out, and which studies are left out of them.
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