In Hospital 24 Hour Observation of Syncope Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

640 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-17

Study Completion Date

2026-08-01

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Syncope

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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discharge

immediate discharge with ambulant HR monitoring (investigational treatment strategy) in low- and intermediate syncope patients in the setting of cardiac emergency room

holter

Intervention Type DIAGNOSTIC_TEST

ambulant heart rate monitor (holter) for 24 hour.

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

holter

Intervention Type DIAGNOSTIC_TEST

ambulant heart rate monitor (holter) for 24 hour.

Interventions

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holter

ambulant heart rate monitor (holter) for 24 hour.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No