Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000766011
Ethics application status
Approved
Date submitted
25/08/2010
Date registered
15/09/2010
Date last updated
18/11/2019
Date data sharing statement initially provided
18/11/2019
Date results information initially provided
18/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Can diagnostic assessment using an ‘Accelerated Pathway’ reduce hospital admissions for chest pain in New Zealand?
Scientific title
A study to compare the effectiveness, when applied to clinical practice of an ‘accelerated’ chest pain diagnostic pathway, against the standard investigative process for adults presenting with possible cardiac chest pain at Christchurch Hospital.
Secondary ID [1] 252568 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiac Chest Pain 258052 0
Condition category
Condition code
Cardiovascular 258212 258212 0 0
Coronary heart disease
Public Health 258303 258303 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Accelerated Arm - Diagnostic assessment using an ‘accelerated’ chest pain pathway. The pathway incorporates using (i) a risk stratification tool, Thrombolysis in Myocardial Infarction Risk Score (TIMI score), (ii) Electrocardiographs (ECGs) AND (iii) troponin blood test over a 2 hour time period from presentation to the hospital.
Intervention code [1] 257084 0
Diagnosis / Prognosis
Comparator / control treatment
Control Arm - Conventional diagnostic assessment pathway according to hospital guidelines involving ECGs and troponin blood test on hospital presentation and a further troponin blood test 8 to 12 hours after pain onset from presentation to the hospital.
Control group
Active

Outcomes
Primary outcome [1] 259076 0
The primary outcome will be the proportion of patients successfully discharged home after Emergency Department (ED) assessment (without admission under another medical specialty to an in-patient ward). Sucessfully discharges is defined as discharged home within 6 hours of arrival at ED and have no serious adverse events. Serious adverse events include;
Death
Cardiac Arrest
Cardiogenic Shock
ST segment elevation myocardial infarction (STEMI)
non-ST segment myocardial infarction (NSTEMI)
Ventricular Arrhythmia
High Level atrioventricular (AV) Block
The research nurses will track the patient's in-hospital progress in real time and use direct questioning of clinicians and patient records in order to record management decisions at initial attendance and admission, extract resource use data and identify subsequent attendances, admissions, and serious adverse events up to three months
Timepoint [1] 259076 0
Discharge home within 6 hours of arrival at ED. - Discharge with no serious adverse event during the following 30 days as determined by follow-up at three months.
Secondary outcome [1] 265355 0
Length of stay (LOS) in hospital. The research nurses will track the patient's in-hospital progress in real time and use direct questioning of clinicians and patient records in order to record management decisions at initial attendance and admission, extract resource use data and identify subsequent attendances, admissions, and adverse events up to three months.
Timepoint [1] 265355 0
Over the 3 months following initial presentation to ED.
Secondary outcome [2] 265356 0
Re-attendance at and/or re-admission to hospital. The research nurses will track the patient's in-hospital progress in real time and use direct questioning of clinicians and patient records in order to record management decisions at initial attendance and admission, extract resource use data and identify subsequent attendances, admissions, and serious adverse events up to three months.
Timepoint [2] 265356 0
At 30 days and at 3 months following initial presentation to ED.
Secondary outcome [3] 265357 0
Serious Adverse Events
Death
Cardiac Arrest
Cardiogenic Shock
ST segment elevation myocardial infarction (STEMI)
non-ST segment myocardial infarction (NSTEMI)
Ventricular Arrhythmia
High Level atrioventricular (AV) Block
The research nurses will track the patient's in-hospital progress in real time and use direct questioning of clinicians and patient records in order to record management decisions at initial attendance and admission, extract resource use data and identify subsequent attendances, admissions, and serious adverse events up to three months
Timepoint [3] 265357 0
At 3 months following initial presentation to ED.
Secondary outcome [4] 265358 0
Proportion of admitted patients ultimately diagnosed as having Acute Myocardial Infarction (AMI) by the European Society of Cardiology/American College of Cardiology (ESC/ACC) criteria
Timepoint [4] 265358 0
in-patient time over 3 months following initial presentation to ED
Secondary outcome [5] 265359 0
Cost effectiveness
The primary form a cost comparison will be the use of hospital inpatient days in each arm.
A secondary cost comparison will be possible using costs of investigation used and re-attendance to hospital
Timepoint [5] 265359 0
3 months following initial presentation to ED
Secondary outcome [6] 265360 0
Health utility measured using the EQ-5D self-complete questionnaire
Timepoint [6] 265360 0
3 months after initial attendance at ED
Secondary outcome [7] 265361 0
Satisfaction with care using a modified Group Health Association of America questionnaire
Timepoint [7] 265361 0
3 month after initial attendance at ED

Eligibility
Key inclusion criteria
1. Adults > 18 years of age
2. Presenting acutely to Christchurch hospital ED with chest pain (or discomfort) suggestive of AMI for whom, following initial clinical assessment, the attending clinician(s) intends to perform serial Cardiac Troponin (cTns), as part of the current chest pain investigation pathway for possible AMI.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. ST Segment Elevation Myocardial Infarction (STEMI) present on any ECG.
2. Aged less than 18 years old
3. Proven or suspected non-coronary pathology as the cause of chest pain
4. Patients who will require admission regardless of a negative cTn, due to other medical conditions, need for other investigations or social considerations.
5. Transfers from other hospitals
6. Chest pain episode began over > 12 hours ago and still persisting pain
7. Subjects previously enrolled in this study
8. Patient (or Legal Representative) unable or unwilling to provide informed consent.
9. Anticipated problem with follow-up e.g. resident outside New Zealand
10. Researcher does not feel that recruitment is appropriate (e.g. terminal illness)

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)
Research nurses will randomise individual patients using a web–based program (allocation concealed) after screening and obtaining consent
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software (i.e., computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Blinding of patients and clinical staff will not be clinically possible, however the primary objectives will be determined by investigators blind to study group assignment and the analyses will be performed by investigators blind to study group assignment.
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
27/09/2010
Actual
11/10/2010
Date of last participant enrolment
Anticipated
Actual
4/07/2012
Date of last data collection
Anticipated
Actual
4/08/2012
Sample size
Target
500
Accrual to date
Final
542
Recruitment outside Australia
Country [1] 2836 0
New Zealand
State/province [1] 2836 0

Funding & Sponsors
Funding source category [1] 257534 0
Government body
Name [1] 257534 0
Health Research Council of New Zealand
Country [1] 257534 0
New Zealand
Funding source category [2] 257535 0
Hospital
Name [2] 257535 0
Canterbury District Health Board
Country [2] 257535 0
New Zealand
Primary sponsor type
Hospital
Name
Canterbury District Health Board
Address
The Princess Margaret Hospital
Cashmere Road
Cashmere
PO Box 1600
Christchurch 8140
Country
New Zealand
Secondary sponsor category [1] 256761 0
Charities/Societies/Foundations
Name [1] 256761 0
Emergency Care Foundation
Address [1] 256761 0
c/o Dr Martin Than
Emergency Department
Riccarton Avenue
Private Bag 4710
Christchurch 8011
Country [1] 256761 0
New Zealand
Other collaborator category [1] 251455 0
Individual
Name [1] 251455 0
Dr Martin Than
Address [1] 251455 0
Emergency Department
Riccarton Avenue
Private Bag 4710
Christchurch 8011
Country [1] 251455 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259564 0
Upper South A Regional Ethics Committee
Ethics committee address [1] 259564 0
Ministry of Health
4th Floor
250 Oxford Terrace
PO Box 3877
Christchurch 8011
Ethics committee country [1] 259564 0
New Zealand
Date submitted for ethics approval [1] 259564 0
Approval date [1] 259564 0
21/07/2010
Ethics approval number [1] 259564 0
URA/10/06/045

Summary
Brief summary
The research will provide an innovative and workable change to the medical decision making involved in the investigation, and service delivery for patients presenting acutely to Emergency Departments (ED’s) with possible cardiac chest pain. It is a randomised trial comparing current care with a new ‘fast-track’ pathway. This research will support research knowledge translation by proving the effectiveness in real-time clinical practice, of the findings of recent, promising, cutting edge, New Zealand research. This research suggests that for significant numbers of patients, an ‘accelerated’ chest pain pathway can rule-out Acute Myocardial Infarction (AMI) sooner, enabling earlier progression to the next phase of chest pain investigation(s) and, importantly, allow early discharge from ED, without hospital admission. It is beneficial for the health service, which avoids unnecessary admissions, duplication of staff activities and pressure upon urgent care services.
Trial website
Trial related presentations / publications
A 2-hour diagnostic protocol for possible cardiac chest pain in the emergency department: a randomized clinical trial. Than M, Aldous S, Lord SJ, et al. JAMA Intern Med. Published online October 7, 2013. doi:10.1001/jamainternmed.2013.11362.
Public notes

Contacts
Principal investigator
Name 31568 0
Dr MARTIN THAN
Address 31568 0
Emergency Department Christchurch Hospital Riccarton Avenue Private Bag 4710 Christchurch 8011
Country 31568 0
New Zealand
Phone 31568 0
+6433640270
Fax 31568 0
Email 31568 0
[email protected]
Contact person for public queries
Name 14815 0
Dr Martin Than
Address 14815 0
Emergency Department
Christchurch Hospital
Riccarton Avenue
Private Bag 4710
Christchurch 8011
Country 14815 0
New Zealand
Phone 14815 0
+64 3 3640 640
Fax 14815 0
Email 14815 0
[email protected]
Contact person for scientific queries
Name 5743 0
Dr Martin Than
Address 5743 0
Emergency Department
Christchurch Hospital
Riccarton Avenue
Private Bag 4710
Christchurch 8011
Country 5743 0
New Zealand
Phone 5743 0
+64 3 3640 640
Fax 5743 0
Email 5743 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Than MP, Aldous S, Lord SJ, Goodacre S, Frampton C... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe utility of presentation and 4-hour high sensitivity troponin I to rule-out acute myocardial infarction in the emergency department.2015https://dx.doi.org/10.1016/j.clinbiochem.2015.07.033
EmbaseAssessment of the 2016 National Institute for Health and Care Excellence high-sensitivity troponin rule-out strategy.2018https://dx.doi.org/10.1136/heartjnl-2017-311983
EmbaseCombining high-sensitivity cardiac troponin i and cardiac troponin T in the early diagnosis of acute myocardial infarction.2018https://dx.doi.org/10.1161/CIRCULATIONAHA.117.032003
EmbaseApplication of high-sensitivity troponin in suspected myocardial infarction.2019https://dx.doi.org/10.1056/NEJMoa1803377
EmbaseDiagnostic and prognostic performance of the ratio between high-sensitivity cardiac troponin I and troponin T in patients with chest pain.2022https://dx.doi.org/10.1371/journal.pone.0276645
N.B. These documents automatically identified may not have been verified by the study sponsor.