24-hour observation for patients with fainting episodes

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

This study is testing if keeping patients with fainting episodes under observation for 24 hours can help doctors decide when it's safe for them to go home instead of sending them home right away.

Quick facts

• Study type: Observational
• Enrollment: 640 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (other)
• Locations: 1 site (Amsterdam)
• Trial ID: NCT06472375 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults assessed as low- and intermediate-risk syncope patients.

Not a fit: Patients under 18 years old or those with serious co-existing conditions will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved management and discharge protocols for syncope patients, enhancing patient care and resource utilization.

How similar studies have performed: While this specific approach has not been tested in a randomized controlled trial, the study builds on existing guidelines and practices in syncope management.

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)

Where this trial is running

Amsterdam

• Amsterdam UMC — Amsterdam, Netherlands (RECRUITING)

Study contacts

• Principal investigator: Frederik de Lange, MD PhD — PI
• Study coordinator: Frederik de Lange, MD PhD

Conditions: Syncope