BAsel Syncope EvaLuation (BASEL IX) Study

Running, not enrolling

Conditions studied: Syncope

In brief

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).

Key facts

Study ID

NCT01548352

Run by

University Hospital, Basel, Switzerland

People needed

3500

Starts

2010-04-01

Expected to finish

2025-12-01

Last updated by the study team

2025-04-15

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients presenting to the emergency department
• Age > 40 years
• Syncope within the last 12 hours
• Written informed consent

You may not qualify if…

• Age < 40 years
• Patients without loss of consciousness and with certain neurological causes (e.g. recurrent epilepsy, hemiplegia at presentation)
• No written informed consent

Where it is running

• Baylor College of Medicine — Houston, Texas, United States
• Instituto Cardiovascular de Buenos Aires — Buenos Aires, Argentina
• Royal Brisbane and Women's hospital — Brisbane, Australia
• Klinikum Nürnberg — Nuremberg, Bavaria, Germany
• Sant'Andrea Hospital — Rome, Italy
• Christchurch Hospital — Christchurch, New Zealand
• Medical University of Silesia — Zabrze, Poland
• Hospital del Mar — Barcelona, Spain
• Hospital Clinic of Barcelona — Barcelona, Spain
• Hospital Universitario Clínico San Carlos — Madrid, Spain
• Kantonsspital Baselland — Liestal, Basel-Landschaft, Switzerland
• Spital Lachen — Lachen, Canton of Schwyz, Switzerland
• University Hospital Basel — Basel, Switzerland
• Luzern Kantonsspital — Lucerne, Switzerland
• University Hospital Zurich — Zurich, Switzerland

Full record on ClinicalTrials.gov

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