ANZCTR - Registration

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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]

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

Condition category

Condition code

Cardiovascular

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]

Diagnosis / Prognosis

Intervention code [2]

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]

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]

30 days, 6 months and 12 months

Secondary outcome [1]

Cardiovascular mortality from deprtment of health data linkage systems

Timepoint [1]

30 days, 6 months and 12 months

Secondary outcome [2]

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]

30 days, 6 months and 12 months

Secondary outcome [3]

Significant bleeding using the GUSTO, TIMI and ACUITY definitions

Timepoint [3]

30 days, 6 months and 12 months

Secondary outcome [4]

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]

First 24 hours from presentation

Secondary outcome [5]

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]

12 months

Secondary outcome [6]

Health economic evaluation of participants:
Health-related quality of life collectd by questionnaire

Timepoint [6]

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

Sex

Both males and females

Can healthy volunteers participate?

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

1/08/2011

Actual

28/07/2011

Date of last participant enrolment

Anticipated

Actual

26/03/2013

Date of last data collection

Anticipated

Actual

Sample size

Target

1937

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Noarlunga Health Service - Noarlunga Centre

Recruitment postcode(s) [1]

5042

Recruitment postcode(s) [2]

5011

Recruitment postcode(s) [3]

5000

Recruitment postcode(s) [4]

5112

Recruitment postcode(s) [5]

5168 - Noarlunga Centre

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

South Australian Department of Health (SA health)

Address [1]

8/45 Grenfell St
Adelaide
SA 5000

Country [1]

Australia

Funding source category [2]

Government body

Name [2]

National Health and Medical Research Council:ID1024008

Address [2]

NH&MRC, GPO Box 1421, Canberra ACT 2601

Country [2]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Southern Adelaide Clinical Human Research ethics Committee

Ethics committee address [1]

Research Ethics office
Room 2A221
Flinders Medical Centre
SA 5042

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

23/05/2011

Approval date [1]

30/06/2011

Ethics approval number [1]

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

Prof Derek Chew

Address

Deprtment of cardiology
Flinders Medical Centre
level 6, FPH
1 Flinders dve
Bedford Park SA 5042

Country

Australia

Phone

+61 8 8404 2001

Fax

derek.chew@flinders.edu.au

Contact person for public queries

Name

Carolyn Astley

Address

Flinders Medical Centre, level 6, FPH, Department of Cardiology, 1 Flinders Dve Bedford Park SA 5042

Country

Australia

Phone

+61 8 8204 6061

Fax

+61 8 8204 5625

carolyn.astley@flinders.edu.au

Contact person for scientific queries

Name

Derek Chew

Address

Flinders Medical Centre, level 6, FPH, Department of Cardiology, 1 Flinders Dve Bedford Park SA 5042

Country

Australia

Phone

+61 8 8404 2001

Fax

+61 8 8204 5625

derek.chew@flinders.edu.au

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

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Randomized comparison of high-sensitivity troponin reporting in undifferentiated chest pain assessment.	2016	https://dx.doi.org/10.1161/CIRCOUTCOMES.115.002488
Embase	Impacts of high sensitivity troponin T reporting on care and outcomes in clinical practice: Interactions between low troponin concentrations and participant sex within two randomized clinical trials.	2023	https://dx.doi.org/10.1016/j.ijcard.2023.131396

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically