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Trial registered on ANZCTR


Trial ID
ACTRN12612000319875
Ethics application status
Approved
Date submitted
20/03/2012
Date registered
21/03/2012
Date last updated
11/04/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Three month outcome of patients with suspected acute coronary syndrome using point of care troponin testing compared with laboratory based troponin testing: a randomised trial
Scientific title
Three month outcome of patients with suspected acute coronary syndrome using point of care troponin testing compared with laboratory based troponin testing: a randomised trial
Secondary ID [1] 280171 0
Nil
Universal Trial Number (UTN)
U1111-1129-2826
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Coronary Syndrome 286103 0
Condition category
Condition code
Cardiovascular 286296 286296 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is sub-study of another trial that is nearing completion. This trial has been registered on the ANZCTR: ACTRN12611001228976, Title: Impact of an Integrated Point of Care Testing service for patients presenting to the Emergency Department on time to disposition decision: a randomised trial. In this trial appropriate patients presenting to the emergency department were randomised to have blood tests performed either by point of care or by the central laboratory. There were two main groups that were enrolled: patients with suspected acute coronary syndrome, and a general group of patients who only needed blood tests from the limited selection available by point of care. Randomisation was stratified according to these two groups. The primary outcome of this trial was time to admission/discharge decision.
This sub-study involves only those patients suspected of an acute coronary syndrome, and following them up at 3 months for clinical outcomes.
Patients suspected of an acute coronary who were randomised to the point of care arm of the study had their first troponin test performed by a point of care device (Radiometer AQT-90). This device takes 12 minutes to process the sample. This test was performed only once.
Intervention code [1] 284500 0
Treatment: Devices
Comparator / control treatment
When patients suspected of an acute coronary are enrolled their first troponin test will be performed by the laboratory based device (5th Generation Roche troponin T assay). This test is performed only once.
Control group
Active

Outcomes
Primary outcome [1] 286767 0
The primary outcome will be a composite of AMI, revascularisation, cardiac arrest and death at 3 months. This will be assessed by medical record review, obtaining death data from the national death registry, phone call to participants at 3 months, and for patients who were not able to be contacted we will utilise the CHeReL service which provide linkage of data from all NSW hospitals which will allow us to identify any admissions to other hospitals.
Timepoint [1] 286767 0
3 months from the time of admission to the Emergency Department
Secondary outcome [1] 296607 0
Secondary outcomes will be each of readmission for chest pain/SOB, further angina, AMI, need for revascularisation, cardiac arrest, or death at 3 months. This will be assessed by medical record review, obtaining death data from the national death registry, phone call to participants at 3 months, and for patients who were not able to be contacted we will utilise the CHeReL service which provide linkage of data from all NSW hospitals which will allow us to identify any admissions to other hospitals.
Timepoint [1] 296607 0
3 months from the time of admission to the Emergency Department
Secondary outcome [2] 298169 0
Economic evaluation
Timepoint [2] 298169 0
all cost associated with medical care at 3 months from the time of admission to the Emergency Department

Eligibility
Key inclusion criteria
18 years or greater
Presentating to the Emergency Department
Suspected on clinical grounds to have an acute coronary syndrome
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
acute ST elevation myocardial infarction

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Study allocation will be recorded on a sheet of paper, each sheet sealed inside opaque sequentially numbered envelopes. These will be stored with the emergency department team co-ordinator (nurse in charge). When a patient meets inclusion criteria, the traeting doctor will ask the team co-ordinator to provide a randomisation envelope. The team co-ordinator will take the next envelope in the sequence and give this to the treating doctor to open.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation sequence was generated using a computerised random number generator. A block randomisation method was used to ensure balanced numbers of participants in each arm of the study. Given that this study is unblinded, block sizes will be mixed to prevent the possibility of predicting the allocation sequence.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Bio-equivalence
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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)

Funding & Sponsors
Funding source category [1] 284921 0
Government body
Name [1] 284921 0
Ministerial Task force for Emergency Care (MTEC)
Address [1] 284921 0
NSW Ministry of Health,
73 Miller Street
North Sydney NSW 2060
Country [1] 284921 0
Australia
Funding source category [2] 284922 0
Hospital
Name [2] 284922 0
St George Hospital
Address [2] 284922 0
Gray St
Kogarah
NSW 2217
Country [2] 284922 0
Australia
Primary sponsor type
Hospital
Name
St George Hospital
Address
Gray St
Kogarah
NSW 2217
Country
Australia
Secondary sponsor category [1] 283795 0
None
Name [1] 283795 0
Address [1] 283795 0
Country [1] 283795 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286920 0
South Eastern Sydney Local Health District HREC (Southern Sector)
Ethics committee address [1] 286920 0
St George Hospital
Gray St
Kogarah
NSW, 2217
Ethics committee country [1] 286920 0
Australia
Date submitted for ethics approval [1] 286920 0
10/01/2012
Approval date [1] 286920 0
15/03/2012
Ethics approval number [1] 286920 0
HREC/12/STG/5

Summary
Brief summary
This is sub-study of another trial that is nearing completion. This trial has been registered on the ANZCTR: ACTRN12611001228976, Title: Impact of an Integrated Point of Care Testing service for patients presenting to the Emergency Department on time to disposition decision: a randomised trial. In this trial appropriate patients presenting to the emergency department were randomised to have blood tests performed either by a point of care device or by the central laboratory. There were two main groups that were enrolled: patients with suspected acute coronary syndrome, and a general group of patients who only needed blood tests from the limited selection available by point of care. Randomisation was stratified according to these two groups. The primary outcome of this trial was time to admission/discharge decision.
This sub-study involves only those patients suspected of an acute coronary syndrome, and following them up at 3 months for clinical outcomes.
The purpose of this study is to demonstrate that performing troponin testing using a point of care device in the emergency department and operated by emergency staff will produce the same clinical outcomes at 3 months amongst patients suspected of having an acute coronary syndrome.
Trial website
Trial related presentations / publications
Public notes
The date that the first patient was enrolled predates the date of ethics approval. This is because this study is following up patient who were enrolled in a separate study (ACTRN12611001228976). Enrolment in the prior study began before this study had been approved. Enrolment of the first patient therefore refer to the date the first patient was enrolled into the prior study.

Contacts
Principal investigator
Name 33944 0
Dr Stephen Asha
Address 33944 0
St George Hospital Gray St Kogarah, NSW, 2217
Country 33944 0
Australia
Phone 33944 0
+61 2 9113 1650
Fax 33944 0
+61 2 9113 1505
Email 33944 0
stephen.asha@sesiahs.health.nsw.gov.au
Contact person for public queries
Name 17191 0
Dr Dr Stephen Asha
Address 17191 0
St George Hospital
Gray St
Kogarah, NSW, 2217
Country 17191 0
Australia
Phone 17191 0
+61 2 9113 1650
Fax 17191 0
+61 2 9113 1505
Email 17191 0
stephen.asha@sesiahs.health.nsw.gov.au
Contact person for scientific queries
Name 8119 0
Dr Dr Stephen Asha
Address 8119 0
St George Hospital
Gray St
Kogarah, NSW, 2217
Country 8119 0
Australia
Phone 8119 0
+61 2 9113 1650
Fax 8119 0
+61 2 9113 1505
Email 8119 0
stephen.asha@sesiahs.health.nsw.gov.au