In Hospital 24 Hour Observation of Syncope Patients (NCT06472375) | Clinical Trial Compass
RecruitingNot Applicable
In Hospital 24 Hour Observation of Syncope Patients
Netherlands640 participantsStarted 2023-11-17
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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
✕. 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
What they're measuring
1
Incidence of Supraventricular tachycardia:
Timeframe: 24 hour after randomization
2
Incidence of Ventricular tachycardia:
Timeframe: 24 hour after randomization
3
Incidence of Conduction disorders:
Timeframe: 24 hour after randomization
4
Incidence of Other events
Timeframe: 24 hour after randomization
Trial details
NCT IDNCT06472375
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)