SyncopeRISCNCT06472375
In Hospital 24 Hour Observation of Syncope Patients
An observational study of Syncope, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Syncope
- What is being tested?
- holter
- How many people
- 640 participants
- Where
- 1 siteNetherlands
- Study dates
- 17 Nov 2023to 1 Aug 2026
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patients attending the Cardiac Emergency Room with low- and intermediate risk syncope.
Who may be able to join
- All patients that are assessed as low- and intermediate risk syncope, are eligible for inclusion in this trial.
- The initial syncope evaluation includes:
- Complete and thorough history taking of the syncope event and past medical history
- Physical examination including supine and standing BP measurement and
- 12 lead ECG.
Who cannot join
- A potential patient who meets any of the following criteria will be excluded from participation in this study:
- Those aged <18 years
- Those in whom syncope / transient loss of consciousness co-exist with trauma or other serious condition identified in the CER (massive bleeding, pulmonary embolus) or any high-risk features upon assessment with guideline based SA
- Those with any other conditions then syncope / transient loss of consciousness for which admission is required (including social indication for admission, etc.)
- Contraindication for early discharge as the discretion of the responsible physician
- Those with a learning disability
- Those presenting with pre-syncope
- Those who are unwilling to provide informed consent (those will be asked to be enrolled for the SYNCOPE R.I.S.C-registry)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Elise Hulsman, RN contact
Netherlands1 site, 1 recruiting
- Recruiting
Amsterdam UMC
Amsterdam, 1105 AZ
Frederik de Lange, MD, PhD, f.j.delange@amsterdamumc.nl
Elise Hulsman, RN, e.l.hulsman@amsterdamumc.nl
About this study
Official title: Multicenter Randomized Clinical Trial to Assess the Clinical Benefit of 24-hour in Hospital Observation of Syncope Patients Admitted to the Cardiac Emergency Room
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).
Read the detailed description
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.
- Conditions
- Syncope
- Being tested
- holter
- Medical subject headings
- Syncope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
holterDiagnostic test
ambulant heart rate monitor (holter) for 24 hour.
| Study group | Role | What they receive |
|---|---|---|
| discharge | immediate discharge with ambulant HR monitoring (investigational treatment strategy) in low- and intermediate syncope patients in the setting of cardiac emergency room Receives: Diagnostic Test: holter | |
| 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 Receives: Diagnostic Test: holter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Supraventricular tachycardia:
- 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
Measured: 24 hour after randomization
Incidence of Ventricular tachycardia:
- 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
Measured: 24 hour after randomization
Incidence of Conduction disorders:
- 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
Measured: 24 hour after randomization
Incidence of Other events
- Syncope recurrence b) Unexplained fall with injury c) All cause death d) Cardiovascular death
Measured: 24 hour after randomization
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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:
- After performing the guideline based syncope algorithm (before enrollment of the patient) and
- At 24 hours after completing each treatment strategy.
Measured: 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).
Measured: 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)'
Measured: 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)'
Measured: up to 1 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start17 Nov 2023
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SyncopeStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The 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
- Other
- Time perspective
- Prospective
- Enrolment
- 640 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frederik de Lange, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Frederik de Lange, MD PhD, Principal investigator, PI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06472375
- Sponsor's protocol ID
- NL 81736.018.22
- Acronym
- RISC
- Status last verified
- Feb 2026
- First submitted
- 13 Feb 2024
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 42282067
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Randomized Clinical Trial to Assess the Clinical Benefit of 24-hour in Hospital Observation of Syncope Patients Admitted to the Cardiac Emergency Room
- ClinicalTrials.gov ID
- NCT06472375
- Acronym / sponsor ID
- RISC / NL 81736.018.22
- Conditions
- Syncope
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 640 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 17 Nov 2023 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 25 Jun 2024 (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.
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).
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| discharge | – | Diagnostic Test: holterimmediate 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 | – | Diagnostic Test: holterdischarge after 24-hour telemetric-observation (reference treatment strategy) in low- and intermediate syncope patients in the setting of cardiac emergency room |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients attending the Cardiac Emergency Room with low- and intermediate risk syncope.
Key inclusion criteria (5 listed)
- All patients that are assessed as low- and intermediate risk syncope, are eligible for inclusion in this trial.
- Complete and thorough history taking of the syncope event and past medical history
- Physical examination including supine and standing BP measurement and
- 12 lead ECG.
Key exclusion criteria (8 listed)
- A potential patient who meets any of the following criteria will be excluded from participation in this study:
- Those aged <18 years
- Those in whom syncope / transient loss of consciousness co-exist with trauma or other serious condition identified in the CER (massive bleeding, pulmonary embolus) or any high-risk features upon assessment with guideline based SA
- Those with any other conditions then syncope / transient loss of consciousness for which admission is required (including social indication for admission, etc.)
- Contraindication for early discharge as the discretion of the responsible physician
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 |
|---|---|---|
| holterambulant heart rate monitor (holter) for 24 hour. | Diagnostic test | admission for 24 hours with rhythmobservation, discharge |
Primary outcome
Incidence of Supraventricular tachycardia:
Time frame: 24 hour after randomization
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
Incidence of Ventricular tachycardia:
Time frame: 24 hour after randomization
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
Incidence of Conduction disorders:
Time frame: 24 hour after randomization
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
Incidence of Other events
Time frame: 24 hour after randomization
a) Syncope recurrence b) Unexplained fall with injury c) All cause death d) Cardiovascular death
6 secondary outcomes
Comparison of Syncope related healthcare costs
Time frame: 1 month
Hospital utilization and duration of total in-hospital stay for both arms
Time frame: 1 month
Proportion of additional diagnoses after both treatment strategies
Time frame: 24 hour after randomization
Assessment of Quality of life (EQ5D - EuroQuol 5Dimensions)
Time frame: up to 1 Month
Assessment of Quality of life (Short Form Health Survey 12)
Time frame: up to 1 Month
Assessment of Quality of life (SyncopeDailyFunctioning)
Time frame: up to 1 Month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Derived from this study: PubMed 42282067Boel 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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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.
Elise Hulsman, RN contact
Frederik de Lange, MD PhD principal investigator
PI
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, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
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 5 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 24 Feb 2026. 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 Netherlands. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Frederik de Lange, MD PhD (+31 (0) 20 5669111, f.j.delange@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Supraventricular tachycardia: (time frame: 24 hour after randomization). The study lists 4 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 NCT06472375, which also lists 1 linked publication.
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 24 Feb 2026.