Clinical trial NCT06472375: In Hospital 24 Hour Observation of Syncope Patients
Official title: Multicenter Randomized Clinical Trial to Assess the Clinical Benefit of 24-hour in Hospital Observation of Syncope Patients Admitted to the Cardiac Emergency Room
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Syncope
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2024-06-25
Enrollment: 640
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients attending the Cardiac Emergency Room with low- and intermediate risk syncope.

Brief 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).

Detailed description: The diagnosis of syncope is a worldwide clinical dilemma. Appropriate identification of low risk vs high risk will reduce inappropriate admission for 24-hour observation with TM. The Dutch Geriatrics Society prioritized syncope management on its research agenda. This project is endorsed by the Dutch Societies of Neurology, Cardiology, Geriatrics, and Internal Medicine and results in freely accessible tutorials on an educational website: www.syncopedia.org.

A randomized clinical trial that includes guideline based SA as routine medical care in the setting of a cardiac emergency room, that compares discharge after 24-hour observation with TM (reference treatment strategy) and immediate discharge (investigational treatment strategy) for low- and intermediate syncope patients will provide new insights and improve syncope health care for these patients.

Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

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)

Primary outcomes:
measure: Incidence of Supraventricular tachycardia:
timeFrame: 24 hour after randomization
measure: Incidence of Ventricular tachycardia:
timeFrame: 24 hour after randomization
measure: Incidence of Conduction disorders:
timeFrame: 24 hour after randomization
measure: Incidence of Other events
timeFrame: 24 hour after randomization
Secondary outcomes:
measure: Comparison of Syncope related healthcare costs
timeFrame: 1 month
measure: Hospital utilization and duration of total in-hospital stay for both arms
timeFrame: 1 month
measure: Proportion of additional diagnoses after both treatment strategies
timeFrame: 24 hour after randomization
measure: Assessment of Quality of life (EQ5D - EuroQuol 5Dimensions)
timeFrame: up to 1 Month
measure: Assessment of Quality of life (Short Form Health Survey 12)
timeFrame: up to 1 Month
measure: Assessment of Quality of life (SyncopeDailyFunctioning)
timeFrame: up to 1 Month
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC
Study officials:
affiliation: PI
name: Frederik de Lange, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: