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Recruiting NCT06472375

In Hospital 24 Hour Observation of Syncope Patients

— Observational Syncope

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: holter.
Who it may be relevant to
Registry conditions: Syncope. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Diagnostic test holter
    ambulant heart rate monitor (holter) for 24 hour.

Primary outcome measures

  • Incidence of Supraventricular tachycardia: [Time frame: 24 hour after randomization]
  • Incidence of Ventricular tachycardia: [Time frame: 24 hour after randomization]
  • Incidence of Conduction disorders: [Time frame: 24 hour after randomization]
  • Incidence of Other events [Time frame: 24 hour after randomization]
Secondary outcome measures (6)
  • 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]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Netherlands · 1 center
  • Amsterdam UMC — Amsterdam

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 PMID 42282067

Identifiers

NCT: NCT06472375 · NL 81736.018.22

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗