NCT06472375 In Hospital 24 Hour Observation of Syncope Patients
| NCT ID | NCT06472375 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
| Condition | Syncope |
| Study Type | OBSERVATIONAL |
| Enrollment | 640 participants |
| Start Date | 2023-11-17 |
| Primary Completion | 2026-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 640 participants in total. It began in 2023-11-17 with a primary completion date of 2026-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
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)
Contact & Investigator
Frederik de Lange, MD PhD
PRINCIPAL INVESTIGATOR
PI
Frequently Asked Questions
Who can join the NCT06472375 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Syncope. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06472375 currently recruiting?
Yes, NCT06472375 is actively recruiting participants. Contact the research team at f.j.delange@amsterdamumc.nl for enrollment information.
Where is the NCT06472375 trial being conducted?
This trial is being conducted at Amsterdam, Netherlands.
Who is sponsoring the NCT06472375 clinical trial?
NCT06472375 is sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). The principal investigator is Frederik de Lange, MD PhD at PI. The trial plans to enroll 640 participants.