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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT01548352
Ethics application status
Date submitted
5/03/2012
Date registered
8/03/2012
Date last updated
30/04/2021

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
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
Sex
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
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2023
Actual
Sample size
Target
3500
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
Trial website
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01548352