Multicenter Randomized Clinical Trial to Assess the Clinical Benefit of 24-hour in Hospital Observation of Syncope Patients Admitted to the Cardiac Emergency Room

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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.

Locations
Other Locations
Netherlands
Amsterdam UMC
RECRUITING
Amsterdam
Contact Information
Primary
Frederik de Lange, MD PhD
f.j.delange@amsterdamumc.nl
+31 (0) 20 5669111
Backup
Elise Hulsman, RN
e.l.hulsman@amsterdamumc.nl
Time Frame
Start Date: 2023-11-17
Estimated Completion Date: 2026-08-01
Participants
Target number of participants: 640
Treatments
discharge
immediate discharge with ambulant HR monitoring (investigational treatment strategy) in low- and intermediate syncope patients in the setting of cardiac emergency room
admission for 24 hours with rhythmobservation
discharge after 24-hour telemetric-observation (reference treatment strategy) in low- and intermediate syncope patients in the setting of cardiac emergency room
Related Therapeutic Areas
Sponsors
Leads: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

This content was sourced from clinicaltrials.gov