Actively Recruiting

Age: 18Years +
All Genders
NCT06472375

In Hospital 24 Hour Observation of Syncope Patients

Led by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Updated on 2026-02-24

640

Participants Needed

1

Research Sites

141 weeks

Total Duration

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AI-Summary

What this Trial Is About

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

Official Title

In Hospital 24 Hour Observation of Syncope Patients

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

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.
Not Eligible

You will not qualify if you...

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)

AI-Screening

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Trial Site Locations

Total: 1 location

1

Amsterdam UMC

Amsterdam, Netherlands, 1105 AZ

Actively Recruiting

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Research Team

F

Frederik de Lange, MD PhD

CONTACT

E

Elise Hulsman, RN

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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