In Hospital 24 Hour Observation of Syncope Patients

NCT06472375 | Recruiting DMC

• 1 other identifier: NL 81736.018.22
• Study Type: observational
• Target: 640
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Syncope

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (6)

• Comparison of Syncope related healthcare costs

  1 month

• Hospital utilization and duration of total in-hospital stay for both arms

  1 month

• Proportion of additional diagnoses after both treatment strategies

  24 hour after randomization

• Assessment of Quality of life (EQ5D - EuroQuol 5Dimensions)

  up to 1 Month

• Assessment of Quality of life (Short Form Health Survey 12)

  up to 1 Month

Study Arms (2)

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

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

Interventions

holter DIAGNOSTIC_TEST

ambulant heart rate monitor (holter) for 24 hour.

admission for 24 hours with rhythmobservation; discharge

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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
• lead ECG.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (1)

Amsterdam UMC

Amsterdam, 1105 AZ, Netherlands

RECRUITING

MeSH Terms

Conditions

Syncope

Interventions

Electrocardiography, Ambulatory

Condition Hierarchy (Ancestors)

Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electrocardiography; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Monitoring, Ambulatory; Monitoring, Physiologic

Study Officials

• Frederik de Lange, MD PhD

  PI

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Frederik de Lange, MD PhD

CONTACT

+31 (0) 20 5669111; f.j.delange@amsterdamumc.nl

Elise Hulsman, RN

CONTACT

e.l.hulsman@amsterdamumc.nl

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: February 13, 2024
• First Posted: June 25, 2024
• Study Start: November 17, 2023
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: February 24, 2026

Record last verified: 2026-02

Locations

NL (1)