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Syncope | BAsel Syncope EvaLuation (BASEL IX) Study

Syncope research study

What is the primary objective of this 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 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).

Who is eligible to participate?

Inclusion Criteria: - Patients presenting to the emergency department - Age > 40 years - Syncope within the last 12 hours - Written informed consent Exclusion Criteria: - Age < 40 years - Patients without loss of consciousness and with certain neurological causes (e.g. recurrent epilepsy, hemiplegia at presentation) - No written informed consent

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Syncope

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Study Status

Recruiting

Start Date: April 2010

Completed Date: December 2022

Phase: N/A

Type: Observational

Design:

Primary Outcome: diagnostic and prognostic value of various novel and established biomarkers, clinical assessment and detailed patient history

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Christian Mueller, MD

Lead Sponsor: University Hospital, Basel, Switzerland

Collaborator: Swiss National Science Foundation

More information:https://clinicaltrials.gov/show/NCT01548352

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