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NCT01548352 · ClinicalTrials.gov registry record
BAsel Syncope EvaLuation (BASEL IX) Study
A clinical trial of Syncope, sponsored by University Hospital, Basel, Switzerland.
- Active
- Registry status
- 3,500
- Enrollment target
- 15
- Study locations
NCT01548352: Active study of Syncope, sponsored by University Hospital, Basel, Switzerland.
NCT01548352 is a study of Syncope that is active but no longer recruiting, run by University Hospital, Basel, Switzerland. The registered enrollment target is 3,500 participants, above the 533-participant average among 11 other Syncope trials with a reported enrollment target (557% higher). The trial reports 15 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01548352, a study of Syncope, is active but no longer recruiting, sponsored by University Hospital, Basel, Switzerland.
- ACTIVE NOT RECRUITING
- Registry status
- 3,500 participants
- Enrollment target
- 15
- Study locations
Study Summary
Syncope is a major health problem. In the emergency department (ED), the management of patients with syncope still remains a clinical challenge because underlying diseases and prognosis can be extremely various. Structural heart disease and primary electrical disorders are major risk factors for sudden cardiac death and mortality in patients with syncope. In contrast, patients with reflex syncope and exclusion of structural heart disease have an excellent prognosis. Therefore The investigators test the hypothesis that the use of a meticulous patient history, clinical examination and novel biomarkers can improve the rapid and accurate diagnosis of cardiac syncope in patients presenting to the ED and is able to improve risk stratification regarding adverse outcomes. The prospective multicenter cohort study is designed to enroll 720 patients presenting with transient loss of consciousness within the last 12 hours to the ED. Blood samples for the measurement of novel biomarkers will be obtained at presentation. All patients will be contacted by phone at 6, 12 and 24 months to determine major adverse events (death, resuscitation, recurrence of syncope, hospitalization for syncope).
Primary Outcome
To test the diagnostic performance of predefined elements of a standardized patient history, overall clinical judgement using a visual analogue scale, and novel biomarkers in the diagnosis of cardiac syncope in patients presenting to the ED.
Conditions Studied
Study Locations (15)
Other
- Instituto Cardiovascular de Buenos Aires - Buenos Aires
- Royal Brisbane and Women's hospital - Brisbane
- Sant'Andrea Hospital - Rome
- Christchurch Hospital - Christchurch
- Medical University of Silesia - Zabrze
- Hospital del Mar - Barcelona
- Hospital Clinic of Barcelona - Barcelona
- Hospital Universitario Clínico San Carlos - Madrid
- University Hospital Basel - Basel
- Luzern Kantonsspital - Lucerne
- University Hospital Zurich - Zurich
Texas
- Baylor College of Medicine - Houston
Bavaria
- Klinikum Nürnberg - Nuremberg
Basel-Landschaft
- Kantonsspital Baselland - Liestal
Canton of Schwyz
- Spital Lachen - Lachen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,500 participants |
| Start Date | 2010-04 |
| Est. Completion | 2025-12 |
What the registry record for NCT01548352 still lists
NCT01548352 is an observational study that tracks outcomes without assigning an intervention. Its 3,500 participants enrollment target places it among the larger protocols in the corpus, above the 533-participant average among 11 other Syncope trials with a reported enrollment target (557% higher).
The record links to 1 condition, with Syncope appearing as the primary indexed condition, and to 0 interventions.
NCT01548352 lists 15 locations in 5 states (Other, Texas, Bavaria).
Frequently Asked Questions
What is clinical trial NCT01548352 about?
NCT01548352 is a clinical study titled "BAsel Syncope EvaLuation (BASEL IX) Study". Syncope is a major health problem. In the emergency department (ED), the management of patients with syncope still remains a clinical challenge because underlying diseases and prognosis can be extremely various. Structural heart disease and primary electrical disorders are major risk factors for sud...
What is the current status of trial NCT01548352?
This trial is currently active not recruiting. The enrollment target is 3,500 participants. The study started on 2010-04. Estimated completion is 2025-12.
What conditions does trial NCT01548352 study?
This clinical trial studies the following conditions: Syncope.
Who is sponsoring clinical trial NCT01548352?
This trial is sponsored by University Hospital, Basel, Switzerland, which has 12 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01548352 being conducted?
This trial has 15 study locations across Texas, Bavaria, Basel-Landschaft, Canton of Schwyz. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01548352's enrollment target sits among peer trials
3,500 1st of 11 higher than 11 of 11 other Syncope trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Syncope trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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