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Trial registered on ANZCTR


Registration number
ACTRN12611000879965
Ethics application status
Approved
Date submitted
11/07/2011
Date registered
17/08/2011
Date last updated
31/03/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
The HS-Troponin study: the effect of 5th generation versus 4th generation troponin-based care on patients with acute coronary syndromes(ACS).
Scientific title
A randomised clinical trial comparing the relative effects of high-sensitivity 5th generation troponin-based care versus 4th generation troponin-based-care in patients with a suspected acute coronary syndrome on clinical events (death, myocardial infarction, recurrent myocardial infarction, revascuarisation, bleeding, stroke) up to 12-months.
Secondary ID [1] 262172 0
Nil
Universal Trial Number (UTN)
U1111-1121-5016
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute coronary syndromes 265857 0
Condition category
Condition code
Cardiovascular 266013 266013 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
High sensitivity 5th-generation Analytic-Sensitvity troponin T(hsTNT) is a blood assay used to refine the diagnostic sensivity of chest pain clinical pathways. It has a detection limit of down to 0.002 micrograms per litre with a 99th percentile of the upper reference limit observed at 0.014 micrograms per litre. It is measured at presentation for medical care and at 3 and 6 hours from baseline and is repeated following coronary revascularisation.
Intervention code [1] 264581 0
Diagnosis / Prognosis
Intervention code [2] 269210 0
Early detection / Screening
Comparator / control treatment
4th-generation Analystic-Sensistivity troponin T (cTNT) is a blood assay used to refine the diagnostic sensivity of chest pain clinical pathways. It has a detection limit of 0.010 micrograms per litre with an unknown 99th percentile of the upper reference limit. However a level of 0.03 micrograms per litre is used to identify patients at elevated risk and a rise and/or fall of beyond 0.1 micrograms per litre to identify myocardial infarction. It is measured at presentation for medical care and at 3 and 6 hours from baseline and is repeated following coronary revascularisation.
Control group
Active

Outcomes
Primary outcome [1] 266770 0
Cumulative composite endpoint of all cause mortality and new or recurrent acute coronary syndrome(ACS) measured beyond the first 24 hours of enrolment. All admissions will be evaluated for evolving ACS and myocardial infarction(MI) after admission using clinical assessment data and test results. All biomarker elevations will be referred for MI adjudication and assessed in a blinded manner to confirm time of criteria and timing of event.
Timepoint [1] 266770 0
30 days, 6 months and 12 months
Secondary outcome [1] 276312 0
Cardiovascular mortality from deprtment of health data linkage systems
Timepoint [1] 276312 0
30 days, 6 months and 12 months
Secondary outcome [2] 276363 0
Unplanned hospital admission for: non-elective coronary revascularsiation, cerebrovascular accident, atrial or ventricular arrythmias, CCF without MI, peripheral revacsularistaion as documented by a hospital discharge summary or diagnosis related gorup report
Timepoint [2] 276363 0
30 days, 6 months and 12 months
Secondary outcome [3] 276364 0
Significant bleeding using the GUSTO, TIMI and ACUITY definitions
Timepoint [3] 276364 0
30 days, 6 months and 12 months
Secondary outcome [4] 287660 0
Diagnostic test evaluation for:
the temporal troponin release among patients with and without adjudicated index MI and ACS, assayed at baseline, 3 and 6 hrs after presentation.
Cardiovascular mortality
Index ACS
Timepoint [4] 287660 0
First 24 hours from presentation
Secondary outcome [5] 287661 0
Health economic evaluation of participants:
In-hospital care from hospital cost data
Resource utilisation from medical benefits schedule(MBS) and pharmaceutical benefits scheme(PBS) data
Timepoint [5] 287661 0
12 months
Secondary outcome [6] 287662 0
Health economic evaluation of participants:
Health-related quality of life collectd by questionnaire
Timepoint [6] 287662 0
Baseline, 30 days, 6 months and 12 months

Eligibility
Key inclusion criteria
Presenting to the emergency department with:
- Clinical features in whom the treating physician seeks to measure the serum troponin level.
- Willing to give informed consent
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients with ST-segment elvation on the presenting ECG
- Inability to complete clinical history questionnaire due to language of co-morbidity.

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)
- Patients who have had a troponin test ordered will be approached for study information delivery and consent.
- Consenting patients are then risk stratified according to Heart Foundation ACS risk strata.
- The research coordinator selects from the appropriately labeled 'risk' box, the next numerically ordered sealed opaque envelope containing the randomisation allocation. This will be concealed from treating clinicians and study personnel in the following way:
each opaque envelope will contain 3 pre-printed pathology forms, each with the same coloured sticker in the top corner.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The sample of 2000 patients will be randomised according to National Heart Foundation risk stratification sub-categories;
Suspected non-ST-segment elevation acute coronary syndrome with high risk features.
Suspected non-ST-segment elevation acute coronary syndrome with intermediate risk features.
Suspected non-ST-segment elevation acute coronary syndrome with low risk features.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Efficacy
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)
Recruitment hospital [1] 2285 0
Noarlunga Health Service - Noarlunga Centre
Recruitment postcode(s) [1] 4061 0
5000
Recruitment postcode(s) [2] 4060 0
5011
Recruitment postcode(s) [3] 4059 0
5042
Recruitment postcode(s) [4] 4067 0
5112
Recruitment postcode(s) [5] 7964 0
5168 - Noarlunga Centre

Funding & Sponsors
Funding source category [1] 267158 0
Government body
Name [1] 267158 0
South Australian Department of Health (SA health)
Address [1] 267158 0
8/45 Grenfell St
Adelaide
SA 5000
Country [1] 267158 0
Australia
Funding source category [2] 289009 0
Government body
Name [2] 289009 0
National Health and Medical Research Council:ID1024008
Address [2] 289009 0
NH&MRC, GPO Box 1421, Canberra ACT 2601
Country [2] 289009 0
Australia
Primary sponsor type
Hospital
Name
Flinders medical centre/Flinders clinical research
Address
1 Flinders Dve
Bedford park SA 5041
Country
Australia
Secondary sponsor category [1] 266234 0
None
Name [1] 266234 0
Address [1] 266234 0
Country [1] 266234 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269150 0
Southern Adelaide Clinical Human Research ethics Committee
Ethics committee address [1] 269150 0
Research Ethics office
Room 2A221
Flinders Medical Centre
SA 5042
Ethics committee country [1] 269150 0
Australia
Date submitted for ethics approval [1] 269150 0
23/05/2011
Approval date [1] 269150 0
30/06/2011
Ethics approval number [1] 269150 0
1/11/0217

Summary
Brief summary
A prospective, single-blind, multicentre, randomised clinical trial to evaluate the clinical impact and resource implications of the high-sensitvity troponin assay in the care of patients presenting with suspected ACS. The study will enroll 2000 patients presenting to an emergency department with clinical features in whom the treating physician seeks to measure serum troponin level. The study will be run across 5 metropolitan public hospitals in Adelaide, South Australia. Patients will be randomised to either the 4th generation or 5th generation troponin reporting system. Information will be collected on presenting chest pain characteristics. Clinical outcomes (death, new/re-MI, bleeding, stroke, revascularisation) including quality of life will be sought in-hospital and at 30 days, 6-months and 12-months and cost effectiveness will be measured at 12-months.
Trial website
None
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 32609 0
Prof Derek Chew
Address 32609 0
Deprtment of cardiology
Flinders Medical Centre
level 6, FPH
1 Flinders dve
Bedford Park SA 5042
Country 32609 0
Australia
Phone 32609 0
+61 8 8404 2001
Fax 32609 0
Email 32609 0
derek.chew@flinders.edu.au
Contact person for public queries
Name 15856 0
Dr Carolyn Astley
Address 15856 0
Flinders Medical Centre, level 6, FPH, Department of Cardiology, 1 Flinders Dve Bedford Park SA 5042
Country 15856 0
Australia
Phone 15856 0
+61 8 8204 6061
Fax 15856 0
+61 8 8204 5625
Email 15856 0
carolyn.astley@flinders.edu.au
Contact person for scientific queries
Name 6784 0
Prof Derek Chew
Address 6784 0
Flinders Medical Centre, level 6, FPH, Department of Cardiology, 1 Flinders Dve Bedford Park SA 5042
Country 6784 0
Australia
Phone 6784 0
+61 8 8404 2001
Fax 6784 0
+61 8 8204 5625
Email 6784 0
derek.chew@flinders.edu.au

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