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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01548352




Registration number
NCT01548352
Ethics application status
Date submitted
5/03/2012
Date registered
8/03/2012
Date last updated
22/11/2019

Titles & IDs
Public title
BAsel Syncope EvaLuation (BASEL IX) Study
Scientific title
BAsel Syncope EvaLuation (BASEL IX) Study
Secondary ID [1] 0 0
BASEL IX
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Syncope 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Diagnostic and prognostic value of various novel and established biomarkers, clinical assessment and detailed patient history - 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.
Timepoint [1] 0 0
within 24 months

Eligibility
Key inclusion criteria
- Patients presenting to the emergency department

- Age > 40 years

- Syncope within the last 12 hours

- Written informed consent
Minimum age
40 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Brisbane and Women's hospital - Brisbane
Recruitment postcode(s) [1] 0 0
QLD 4029 - Brisbane
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Texas
Country [2] 0 0
Argentina
State/province [2] 0 0
Buenos Aires
Country [3] 0 0
Germany
State/province [3] 0 0
Bavaria
Country [4] 0 0
Italy
State/province [4] 0 0
Rome
Country [5] 0 0
New Zealand
State/province [5] 0 0
Christchurch
Country [6] 0 0
Poland
State/province [6] 0 0
Zabrze
Country [7] 0 0
Spain
State/province [7] 0 0
Barcelona
Country [8] 0 0
Spain
State/province [8] 0 0
Madrid
Country [9] 0 0
Switzerland
State/province [9] 0 0
Baselland
Country [10] 0 0
Switzerland
State/province [10] 0 0
Schwyz
Country [11] 0 0
Switzerland
State/province [11] 0 0
Basel
Country [12] 0 0
Switzerland
State/province [12] 0 0
Luzern
Country [13] 0 0
Switzerland
State/province [13] 0 0
Zurich

Funding & Sponsors
Primary sponsor type
Other
Name
University Hospital, Basel, Switzerland
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Swiss National Science Foundation
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief 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).
Trial website
https://clinicaltrials.gov/show/NCT01548352
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Christian Mueller, MD
Address 0 0
University Hospital, Basel, Switzerland
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Christian Mueller, MD
Address 0 0
Country 0 0
Phone 0 0
0041-61-2652525
Fax 0 0
Email 0 0
christian.mueller@usb.ch
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT01548352