In Hospital 24 Hour Observation of Syncope Patients

Recruiting now

Conditions studied: Syncope

In brief

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).

Key facts

Study ID

NCT06472375

Run by

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

People needed

640

Starts

2023-11-17

Expected to finish

2026-08-01

Last updated by the study team

2026-02-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

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)

Where it is running

• Amsterdam UMC — Amsterdam, Netherlands (enrolling)

Full record on ClinicalTrials.gov

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