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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Retrospectively registered

Titles & IDs
Public title
Using Brain-Natriuretic Peptide (blood test for heart failure) and the San Francisco Syncope Rule to reduce hospital admissions for fainting.
Scientific title
Adding the Brain-Natriuretic Peptide (BNP) blood test to the San Francisco Syncope Rule to reduce hospital admissions from the emergency department with syncope.
Secondary ID [1] 280275 0
Universal Trial Number (UTN)
Trial acronym
Syncope Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Syncope 286228 0
Condition category
Condition code
Neurological 286445 286445 0 0
Other neurological disorders
Public Health 286446 286446 0 0
Health service research
Cardiovascular 286646 286646 0 0
Diseases of the vasculature and circulation including the lymphatic system

Study type
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
An additional 5ml of blood will be drawn with the initial blood taken for standard clinical managment during patients presentation to ED for syncope. If blood is not being taken for clinical care, patient will be asked if they wish to take part in the study and provide a blood sample. The blood will be tested for Brain-Natriuretic peptide levels using the Alere Triage machine. There will be no storage of blood, other than temporarily if the testing needs to be done at a later date.

Data will be collected using a standardised data collection form. Patients will be managed and discharged as determined by their treating clinician as per their clinical judgement - the trial blood sample will not be available to clinicians.

Patients will be recruited for 12 months with the aim for at least 450 patients.

Patients will be telephoned by research nurses at approximately 30 days post ED discharge and asked a series of standard questions regarding their health and investigations since ED discharge. Hospital summaries and results of investigations will be obtained by research staff.

The San Franciso Rule will be applied to the patient data retrospectively, there will be no change to patient care. The San Francisco Rule considers patients with an abnormal ECG, a complaint of shortness of breath, haematocrit less than 30%, systolic blood pressure less than 90 mm Hg or a history of congestive heart failure is at risk of an adverse outcome and should be admitted for futher investigation.
Intervention code [1] 284627 0
Not applicable
Comparator / control treatment
Standard clinical management of syncope, will be as deemed appropriate by the treating physician with no reference made to the San Francisco rule or the syncope research study.
Control group

Primary outcome [1] 286892 0
Serious adverse outcome. Serious adverse outcome is defined as any of: Death, AMI, arrhythmia, pulmonary embolism, stroke, subarachnoid haemorhage, significant haemorrhage or any condition causing or likely to cause a return ED visit and hospitalisation for a related event.

Death will be determined from hospital records or the hospital morbidity system which is reguarly updated from the WA Births and Deaths Registry.

Myocardial Infarction: The definition will be any elevation of troponin or ECG change with an accompanying diagnosis and confirmed by the treating consultant.

Pulmonary Embolism: Determined by ventilation perfusion scanning, computed tomography (CT) of the chest or angiography or confirmed on autopsy.

Stroke: Determined by discharge diagnosis asssigned by treating consultant.

Subarachnoid haemorhage: Determined by discharge diagnosis asssigned by the treating consultant.

Significant Haemorrhage: Source of bleeding that required transfusion or other therapeutic intervention eg. iron infusion.

Arrhythmia:To be captured on monitoring and thought to have had a temporal relationship to the syncopal or near syncopal event. The treating consultant will determine whether there was a temporal relationship to the syncope event.

Representation to the ED resulting in hospital admission, with a condition that can be related back to the original syncopal event. This will be determined by the PI's.
Timepoint [1] 286892 0
Within 30 days of Emergency Department attendence
Secondary outcome [1] 296922 0
Timepoint [1] 296922 0

Key inclusion criteria
Patients presenting to Hospital Emergency Departments with “Collapse”, “Syncope” or “Faint” will be eligible for recruitment.
Minimum age
18 Years
Maximum age
No limit
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
Patients < 18 years old, pregnancy,altered mental state, alcohol or illicit drug-related loss of consciousness, a definite seizure or transient loss of consciousness caused by head trauma, inability to obtain consent, and likely inability to conduct follow-up (e.g. overseas visitors).

Study design
Convenience sample
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285049 0
Name [1] 285049 0
Fremantle Hospital Medical Research Foundation
Address [1] 285049 0
Alma Street
PO Box 480
Fremantle WA 6959
Country [1] 285049 0
Primary sponsor type
Karen Shakespeare
Fremantle Hospital Emeregency Medicine Research Unit
PO Box 480
Fremantle WA 6959
Secondary sponsor category [1] 283913 0
Name [1] 283913 0
Yusuf Nagree
Address [1] 283913 0
Fremantle Hospital Emergency Medicine Research Unit
PO Box 480
Fremantle WA 6959
Country [1] 283913 0
Other collaborator category [1] 260715 0
Name [1] 260715 0
Stephen MacDonald
Address [1] 260715 0
Armadale Health Service
PO Box 460
Armadale WA 6992
Country [1] 260715 0

Ethics approval
Ethics application status
Ethics committee name [1] 287054 0
South Metropolitan Area Health Service HREC
Ethics committee address [1] 287054 0
c/- Fremantle Hospital
PO Box 480
Fremantle WA 6959
Ethics committee country [1] 287054 0
Date submitted for ethics approval [1] 287054 0
Approval date [1] 287054 0
Ethics approval number [1] 287054 0

Brief summary
Patients that present to Emergency Departments with syncope are some of the most difficult to diagnose. Syncope (fainting, collapse) is a temporary loss of consciousness with a spontaneous return to normal function. There are many causes of syncope, some serious and some trivial. There are a number of ways to determine whether a patient has a serious cause (and should be admitted to hospital and undergo further testing and observation) or a trivial cause and can be discharged home. One way is the San Francisco Rule, which looks at five factors. These factors are: using the acronym CHESS, C-history of congestive cardiac failure, H-haematocrit <30%, E-abnormal ECG, S- shortness of breath, S- systolic blood pressure <90. However, the accuracy of this rule is variable. There have been suggestions that looking at an additional factor, like a specific blood test for heart failure, may improve the accuracy of this rule.

The aim of this project is to determine whether the use of the San Francisco Syncope Rule (SFR) with the addition of a Brain-Naturetic Peptide (BNP) blood test can result in an improvement in the outcomes of patients who present to Emergency Departments (ED) with syncope.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 34021 0
Mrs Karen Shakespeare
Address 34021 0
Fremantle Hospital Emergency Medicine Research Unit Fremantle Hospital PO Box 480 Fremantle WA 6959
Country 34021 0
Phone 34021 0
+61 08 9431 3733
Fax 34021 0
Email 34021 0
Contact person for public queries
Name 17268 0
Mrs Karen Shakespeare
Address 17268 0
Fremantle Hospital Emergency Medicine Research Unit
Fremantle Hospital
PO Box 480
Fremantle WA 6959
Country 17268 0
Phone 17268 0
+61 08 9431 3733
Fax 17268 0
+61 08 9431 3073
Email 17268 0
Contact person for scientific queries
Name 8196 0
Mrs Karen Shakespeare
Address 8196 0
Fremantle Hospital Emergency Medicine Research Unit
Fremantle Hospital
PO Box 480
Fremantle WA 6959
Country 8196 0
Phone 8196 0
+61 08 9431 3733
Fax 8196 0
+61 08 9431 3073
Email 8196 0

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary