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NCT Number: NCT06472375

In Hospital 24 Hour Observation of Syncope Patients

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).

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Amsterdam UMC

Amsterdam, 1105 AZ, Netherlands

Location status: Recruiting

Location contact

Elise Hulsman, RN

CONTACT

[email protected]

Frederik de Lange, MD, PhD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:

  • 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.

Exclusion criteria

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)

Treatment and study plan

holter

Diagnostic Test

ambulant heart rate monitor (holter) for 24 hour.

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Secondary outcomes

  1. Comparison of Syncope related healthcare costs

    Time frame: 1 month

    Health care costs will be calculated on the basis of the tariffs set by the schedule of the Dutch National Health Service.

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

    Time frame: 1 month

    Hospital utilization of both treatment strategies will be quantified by the duration of the in-hospital stay from the moment of randomization.

  3. Proportion of additional diagnoses after both treatment strategies

    Time frame: 24 hour after randomization

    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.

  4. Assessment of Quality of life (EQ5D - EuroQuol 5Dimensions)

    Time frame: up to 1 Month

    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).

  5. Assessment of Quality of life (Short Form Health Survey 12)

    Time frame: up to 1 Month

    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)'

  6. Assessment of Quality of life (SyncopeDailyFunctioning)

    Time frame: up to 1 Month

    Questionnaire to assess qyality of life in daily functioning. Questionnaire contains closed questions with different response options. 'Yes/no' or '1(negative)-8(positive)'

Study contacts

Contact information is provided by the study sponsor or research team.

Elise Hulsman, RN

CONTACT

[email protected]

Frederik de Lange, MD PhD

CONTACT

[email protected]

+31 (0) 20 5669111

Sponsors and collaborators

Lead sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Other

Registry information

Official study 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

Acronym: RISC

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jun 25, 2024
Registry last updated
Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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