In Hospital 24 Hour Observation of Syncope Patients (RISC)

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).

Study Overview

• Status: Recruiting
• Conditions: Syncope
• Intervention / Treatment: Diagnostic test: holter

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 Type: Observational
• Enrollment (Estimated): 640

Contacts and Locations

• Study Contact: Name: Frederik de Lange, MD PhD; Phone Number: +31 (0) 20 5669111; Email: f.j.delange@amsterdamumc.nl
• Study Contact Backup: Name: Elise Hulsman, RN; Email: e.l.hulsman@amsterdamumc.nl

Study Locations

• Netherlands
  • Amsterdam, Netherlands, 1105 AZ
    • Recruiting
    • Amsterdam UMC
    • Contact: Elise Hulsman, RN; Email: e.l.hulsman@amsterdamumc.nl
    • Contact: Frederik de Lange, MD, PhD; Email: f.j.delange@amsterdamumc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients attending the Cardiac Emergency Room with low- and intermediate risk syncope.

Description

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:

1. Complete and thorough history taking of the syncope event and past medical history
2. Physical examination including supine and standing BP measurement and
3. 12 lead ECG.

Exclusion Criteria:

A potential patient who meets any of the following criteria will be excluded from participation in this study:

1. Those aged <18 years
2. 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
3. Those with any other conditions then syncope / transient loss of consciousness for which admission is required (including social indication for admission, etc.)
4. Contraindication for early discharge as the discretion of the responsible physician
5. Those with a learning disability
6. Those presenting with pre-syncope
7. Those who are unwilling to provide informed consent (those will be asked to be enrolled for the SYNCOPE R.I.S.C-registry)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
discharge; 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; ambulant heart rate monitor (holter) for 24 hour.
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	Diagnostic test: holter; ambulant heart rate monitor (holter) for 24 hour.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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: After performing the guideline based syncope algorithm (before enrollment of the patient) and; At 24 hours after completing each treatment strategy.	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

Collaborators and Investigators

• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Investigators: Principal Investigator: Frederik de Lange, MD PhD, PI

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2023
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: February 13, 2024
• First Submitted That Met QC Criteria: June 24, 2024
• First Posted (Actual): June 25, 2024

Study Record Updates

• Last Update Posted (Actual): February 24, 2026
• Last Update Submitted That Met QC Criteria: February 23, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neurobehavioral Manifestations; Consciousness Disorders; Unconsciousness; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Syncope; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Cardiovascular; Heart Function Tests; Electrodiagnosis; Monitoring, Physiologic; Electrocardiography; Monitoring, Ambulatory; Electrocardiography, Ambulatory
• Other Study ID Numbers: NL 81736.018.22

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No