In Hospital 24 Hour Observation of Syncope Patients
Multicenter Randomized Clinical Trial to Assess the Clinical Benefit of 24-hour in Hospital Observation of Syncope Patients Admitted to the Cardiac Emergency Room
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
640 participants
Nov 17, 2023
OBSERVATIONAL
Conditions
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).
Eligibility
Inclusion Criteria5
- 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
- lead ECG.
Exclusion Criteria8
- 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)
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Interventions
ambulant heart rate monitor (holter) for 24 hour.
Locations(1)
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NCT06472375