24-hour observation for patients with fainting episodes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate the effectiveness of a 24-hour observation period with telemetry for low- and intermediate-risk syncope patients compared to immediate discharge. It will utilize a guideline-based syncope algorithm to identify eligible patients in a cardiac emergency room setting. The study seeks to clarify the optimal discharge timing for these patients, potentially reducing unnecessary hospital admissions. The findings will be supported by educational resources developed in collaboration with various Dutch medical societies.

Why it matters

Who can join: the full rules

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)

Where it's running

• Amsterdam UMC
  Amsterdam, Netherlands Recruiting

Study contacts

• Principal investigator: Frederik de Lange, MD PhD — Pi
• Study coordinator: Frederik de Lange, MD PhD
• Email: f.j.delange@amsterdamumc.nl
• Phone: +31 (0) 20 5669111

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.