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Trial registered on ANZCTR


Registration number
ACTRN12609000283279
Ethics application status
Approved
Date submitted
30/03/2009
Date registered
15/05/2009
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
Retrospectively registered

Titles & IDs
Public title
1. ASPECT - ASIA PACIFIC EVALUATION OF CHEST PAIN TRIAL An observational study of the diagnostic utility of a biomarker panel in the assessment of patients presenting to asia-paciifc hospitals with chest pain of possible cardiac origin
Scientific title
1. ASPECT - ASIA PACIFIC EVALUATION OF CHEST PAIN TRIAL An observational study of the diagnostic utility of a biomarker panel in the assessment of patients presenting to asia-paciifc hospitals with chest pain of possible cardiac origin
Secondary ID [1] 263111 0
ASPECT
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chest pain of possible cardiac origin 4540 0
Condition category
Condition code
Cardiovascular 4829 4829 0 0
Coronary heart disease

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
ASPECT: The Triage multi-marker panel consists of measurements of Troponin I, Creatine Kinase MB (CKMB) and myoglobin levels using a point of care testing device for blood samples taken from people who present with probable ischaemic chest pain to the Emergency Department. A sample is tested on arrival and again 2 hours later.
Intervention code [1] 4304 0
Not applicable
Comparator / control treatment
n/a
Control group
Uncontrolled

Outcomes
Primary outcome [1] 5691 0
ASPECT:To prospectively validate an accelerated chest pain algorithm involving Troponin I, Creatine Kinase MB (CKMB) and Myoglobin Delta measurements over a 2 hour time period from presentation to the Emergency Department (ED) in patients with possible Acute Coronary Syndrome (ACS) using the Biosite Triage point of care multi-marker panel
Timepoint [1] 5691 0
At presention to ethe emergency departmetn at Christchurch Hospital and again 2 hours later
Secondary outcome [1] 241596 0
To determine the potential cost benefit of such a strategy in terms of case weight costing and bed days.
Timepoint [1] 241596 0
From presenation to the Emergency Department at trial hospital , then at 30 days and 1 year for all cause readmission(s) and/or death.

Eligibility
Key inclusion criteria
Adults presenting to the trial hospital Emergency Department with chest pain of possible cardiac origin
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Age < 18 years. Non-resident in country of recruitment. Patients for whom follow-up will not be possible either due to lack of onward contact address or because they will be overseas. Unable or unwilling to consent

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
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)
QLD
Recruitment postcode(s) [1] 2637 0
4029
Recruitment outside Australia
Country [1] 1706 0
New Zealand
State/province [1] 1706 0
Country [2] 1707 0
India
State/province [2] 1707 0
Delhi
Country [3] 1708 0
Singapore
State/province [3] 1708 0
Singapore
Country [4] 1709 0
China
State/province [4] 1709 0
Beijing
Country [5] 1710 0
Hong Kong
State/province [5] 1710 0
Hong Kong
Country [6] 1711 0
Indonesia
State/province [6] 1711 0
Jakarta
Country [7] 1712 0
Thailand
State/province [7] 1712 0
Bangkok
Country [8] 1713 0
Taiwan, Province Of China
State/province [8] 1713 0
Taipei
Country [9] 1714 0
Korea, Democratic People's Republic Of
State/province [9] 1714 0
Seoul

Funding & Sponsors
Funding source category [1] 4731 0
Commercial sector/Industry
Name [1] 4731 0
Inverness Medical Innovations
Address [1] 4731 0
532 Seventeen Miles Rocks Rd
Sinnamon Park, QLD 4073
Country [1] 4731 0
Australia
Funding source category [2] 269935 0
Government body
Name [2] 269935 0
Health Research Council New Zealand
Address [2] 269935 0
PO Box 5541, Wellesley Street, Auckland 1141
Country [2] 269935 0
New Zealand
Funding source category [3] 269936 0
Government body
Name [3] 269936 0
National Health and Medical Research (Australia)
Address [3] 269936 0
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Country [3] 269936 0
Australia
Funding source category [4] 269937 0
Charities/Societies/Foundations
Name [4] 269937 0
Christchurch Cardio-Endocrine Research Group
Address [4] 269937 0
Department of Medicine
Christchurch Hospital
New Zealand
Country [4] 269937 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Inverness Medical Innovations
Address
532 Seventeen Miles Rocks Rd
Sinnamon Park, QLD 4073
Country
Australia
Secondary sponsor category [1] 4273 0
Charities/Societies/Foundations
Name [1] 4273 0
Emergency Care Foundation
Address [1] 4273 0
Emergency Department
Christchurch Hospital
PO Box 4710
Christchurch
Country [1] 4273 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6772 0
Upper South A Regional Ethics Committee
Ethics committee address [1] 6772 0
Ministry of health
PO Box 3877
Christchurch
Ethics committee country [1] 6772 0
New Zealand
Date submitted for ethics approval [1] 6772 0
Approval date [1] 6772 0
26/07/2007
Ethics approval number [1] 6772 0

Summary
Brief summary
This is a prospective observational study of the diagnostic utility of the "Triage" multi-marker point of care blood testing device to measure the levels of the cardiac markers Troponin I, Creatine Kinase MB and myoglobin:
- in people presenting to the Emergency Deprtment with chest pain of probable caridac origin. Blood samples will be taken and tested on arrival and again at 2 hours. Participants will undergo risk evaluation by a means of a set series of questions. Participants will recieve a phone call at 45 days, 6 months and 1 year post discharge to record any major adverse cardiac event (MACE) they may have experienced.
Trial website
Trial related presentations / publications
Than, M. P., Cullen, L., Reid, C. M., Lim, S. H., Aldous, S., Ardagh, M. W., et al. (2011). A 2-h diagnostic protocol to assess patients with chest pain symptoms in the Asia-Pacific region (ASPECT): a prospective observational validation study. Lancet, 377(9771), 1077–1084. doi:10.1016/S0140-6736(11)60310-3
Public notes

Contacts
Principal investigator
Name 29448 0
Dr Martin Than
Address 29448 0
Emergency Department
Christchurch Hospital
Private Bag 4710
Christchurch
Country 29448 0
New Zealand
Phone 29448 0
00643 364 0270
Fax 29448 0
Email 29448 0
martin.than@cdhb.health.nz
Contact person for public queries
Name 12695 0
Dr Dr Martin Than
Address 12695 0
Emergency Department
Christchurch Hospital
PO Box 4710
Christchurch
Country 12695 0
New Zealand
Phone 12695 0
+643 364 0270
Fax 12695 0
+643 364 0286
Email 12695 0
martin.than@cdhb.govt.nz
Contact person for scientific queries
Name 3623 0
Dr Dr Martin Than
Address 3623 0
Emergency Department
Christchurch Hospital
PO Box 4710
Christchurch
Country 3623 0
New Zealand
Phone 3623 0
+643 364 0270
Fax 3623 0
+643 364 0286
Email 3623 0
martin.than@cdhb.govt.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No ethics permission
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
Yes
Journal publication details
Publication date and citation/details [1] 5730 0
Than MP, Cullen LA, Reid CM, Lim SH, Aldous S, Ardagh MW, et al. A 2-h diagnostic protocol to assess patients with chest pain symptoms in the Asia-Pacific region (ASPECT): a prospective observational validation study. Lancet. 2011;377(9771):1077–84.
Attachments [1] 5730 0
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary