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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| discharge | immediate discharge with ambulant HR monitoring (investigational treatment strategy) in low- and intermediate syncope patients in the setting of cardiac emergency room |
| |
| admission for 24 hours with rhythmobservation | discharge after 24-hour telemetric-observation (reference treatment strategy) in low- and intermediate syncope patients in the setting of cardiac emergency room |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| holter | Diagnostic Test | ambulant heart rate monitor (holter) for 24 hour. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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 | 24 hour after randomization |
| Incidence of Other events | a) Syncope recurrence b) Unexplained fall with injury c) All cause death d) Cardiovascular death | 24 hour after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 month |
| Hospital utilization and duration of total in-hospital stay for both arms |
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Inclusion Criteria:
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:
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Patients attending the Cardiac Emergency Room with low- and intermediate risk syncope.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Frederik de Lange, MD PhD | Contact | +31 (0) 20 5669111 | f.j.delange@amsterdamumc.nl | |
| Elise Hulsman, RN | Contact | e.l.hulsman@amsterdamumc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Frederik de Lange, MD PhD | PI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amsterdam UMC | Recruiting | Amsterdam | 1105 AZ | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42282067 | Derived | Boel TT, Peeters SYG, van Alem AP, Boogers MJ, Bootsma M, van den Dorpel MA, Firouzi M, Groothuis JGJ, Hemels MEW, Houtgraaf JH, Jansen WPJ, de Jong JSY, Jongenotter M, Kaal ECA, Koomen EM, Langerak SE, Mairuhu G, Mullaart NE, van Rees JB, Samim M, Wierda E, van Zanten S, van Zoelen A, van Barreveld M, Croon PM, Dijkgraaf MGW, Tijssen JGP, De Groot JR, de Lange FJ. Design and rationale of the RISC-trial: multicentre RCT to assess immediate discharge of syncope patients admitted to the (cardiac) emergency room. Eur Heart J Open. 2026 May 14;6(3):oeag078. doi: 10.1093/ehjopen/oeag078. eCollection 2026 May. |
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| ID | Term |
|---|---|
| D013575 | Syncope |
| ID | Term |
|---|---|
| D014474 | Unconsciousness |
| D003244 | Consciousness Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D015716 | Electrocardiography, Ambulatory |
| ID | Term |
|---|---|
| D004562 | Electrocardiography |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
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Hospital utilization of both treatment strategies will be quantified by the duration of the in-hospital stay from the moment of randomization. |
| 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:
| 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). | 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)' | 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)' | up to 1 Month |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003933 | Diagnosis |
| D004568 | Electrodiagnosis |
| D018670 | Monitoring, Ambulatory |
| D008991 | Monitoring, Physiologic |