Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12611001069943
Ethics application status
Approved
Date submitted
5/10/2011
Date registered
14/10/2011
Date last updated
14/10/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
A 2hr Accelerated Diagnostic Protocol to Assess patients with chest Pain symptoms using contemporary Troponins as the only biomarker (ADAPT): a prospective observational validation study
Scientific title
An observational study of the diagnostic utility of an accelerated diagnostic protocol using contemporary central laboratory cardiac troponin in the assessment of patients presenting to two Australasian hospitals with chest pain of possible cardiac origin
Secondary ID [1] 273172 0
ADAPT and ASPECT (ACTRN12609000283279) are parallel studies both of which are part of the Austalia New Zealand Acute Chest Pain (ANZACP) registry. Both studies began at the same time Sept. 2007 but ADAPT continue for longer until February 2011. The studies used a common participant recruitment and outcomes determination process but index test biomarker analysis was performed completely separately.
Universal Trial Number (UTN)
Trial acronym
ADAPT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chest pain of possible cardiac origin 278924 0
Condition category
Condition code
Cardiovascular 279103 279103 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
A risk assessment will be made using the TIMI score , ECG and measurements of central lab Troponin I 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.
ADAPT and ASPECT both started in Christchurch in November 2007 final recruitment for ASPECT occured in Singapore in July 2010; recruitment for ADAPT finished in Brisbane February 2011
Intervention code [1] 269503 0
Not applicable
Comparator / control treatment
Observational validation study of diagnostic accuracy.
No intervention or change occured to patient management.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 279744 0
To prospectively validate an accelerated chest pain algorithm involving core lab Troponin I measurements over a 2 hour time period from presentation to the Emergency Department (ED) in patients with possible Acute Coronary Syndrome (ACS).
Occurence of patient outcomes at 30 days and 1 year post presentation will be determined using patient follow-up at 45 days, 6 months and 1 year post presentation.
Timepoint [1] 279744 0
30 days post-presentation
Secondary outcome [1] 294355 0
To determine the potential cost benefit for the health service of such a strategy in terms of case weight costing and bed days.
Timepoint [1] 294355 0
From presentation 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
Sex
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
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
6/11/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
2000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 3903 0
New Zealand
State/province [1] 3903 0
Canterbury

Funding & Sponsors
Funding source category [1] 269988 0
Commercial sector/Industry
Name [1] 269988 0
Abbott Diagnostics
Country [1] 269988 0
United States of America
Funding source category [2] 269989 0
Government body
Name [2] 269989 0
Health Research Council New Zealand
Country [2] 269989 0
New Zealand
Funding source category [3] 269990 0
Charities/Societies/Foundations
Name [3] 269990 0
Christchurch Cardio-Endocrine Research Group
Country [3] 269990 0
New Zealand
Funding source category [4] 269991 0
Government body
Name [4] 269991 0
National Health and Medical Research Council (Australia)
Country [4] 269991 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Christchurch Cardio-Endocrine Research Group
Address
Christchurch Hospital
CHristchurch
private bag 4710
Country
New Zealand
Secondary sponsor category [1] 268977 0
Charities/Societies/Foundations
Name [1] 268977 0
Emergency Care Foundation
Address [1] 268977 0
Emergency Department
Christchurch Hospital
PO Box 4710
Christchurch
Country [1] 268977 0
New Zealand
Other collaborator category [1] 252289 0
Commercial sector/Industry
Name [1] 252289 0
Abbott Diagnostics
Address [1] 252289 0
100 Abbott Park Road
Abbott Park, IL 60064-6083
Country [1] 252289 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271953 0
Upper South A Regional Ethics Committee
Ethics committee address [1] 271953 0
Ministry of health
PO Box 3877
Christchurch
Ethics committee country [1] 271953 0
New Zealand
Date submitted for ethics approval [1] 271953 0
Approval date [1] 271953 0
26/07/2007
Ethics approval number [1] 271953 0

Summary
Brief summary
This is a prospective observational study of the diagnostic utility of an accelerated diagnostic protocol using a central laboratory Troponin I in people presenting to the Emergency Deprtment with chest pain of probable caridac origin. A blood sample 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. Patients will be followed-up to determine outcomes at 30 days and 1 year after presentation
Trial website
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 33243 0
Address 33243 0
Country 33243 0
Phone 33243 0
Fax 33243 0
Email 33243 0
Contact person for public queries
Name 16490 0
Dr Martin Than
Address 16490 0
Emergency Department
Christchurch Hospital
PO Box 4710
Christchurch
Country 16490 0
New Zealand
Phone 16490 0
+643 364 0270
Fax 16490 0
+643 364 0286
Email 16490 0
[email protected]
Contact person for scientific queries
Name 7418 0
Dr Martin Than
Address 7418 0
Emergency Department
Christchurch Hospital
PO Box 4710
Christchurch
Country 7418 0
New Zealand
Phone 7418 0
+643 364 0270
Fax 7418 0
+643 364 0286
Email 7418 0
[email protected]

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
Current Study Results
No documents have been uploaded by study researchers.

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
4323Study results articleYes Than MP, Cullen LA, Aldous S, Parsonage WA, Reid C... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseTime to presentation and 12-month health outcomes in patients presenting to the emergency department with symptoms of possible acute coronary syndrome.2016https://dx.doi.org/10.1136/emermed-2015-204978
EmbaseNICE algorithms based on high-sensitivity troponin assays ruled out AMI, but > 8.5% had MACE at 30 days.2016https://dx.doi.org/10.7326/ACPJC-2016-165-8-047
EmbaseHeart Fatty Acid Binding Protein and cardiac troponin: Development of an optimal rule-out strategy for acute myocardial infarction.2016https://dx.doi.org/10.1186/s12873-016-0089-y
EmbaseDetectable high-sensitivity cardiac troponin within the population reference interval conveys high 5-year cardiovascular risk: An observational study.2018https://dx.doi.org/10.1373/clinchem.2017.285700
EmbaseDirect comparison of 2 rule-out strategies for acute myocardial infarction: 2-h accelerated diagnostic protocol vs 2-h algorithm.2017https://dx.doi.org/10.1373/clinchem.2016.268359
Dimensions AI2-Hour Accelerated Diagnostic Protocol to Assess Patients With Chest Pain Symptoms Using Contemporary Troponins as the Only Biomarker The ADAPT Trial2012https://doi.org/10.1016/j.jacc.2012.02.035
Dimensions AIDiagnosis of acute myocardial infarction in the presence of left bundle branch block2019https://doi.org/10.1136/heartjnl-2018-314673
Dimensions AIDiagnostic and prognostic performance of the ratio between high-sensitivity cardiac troponin I and troponin T in patients with chest pain2022https://doi.org/10.1371/journal.pone.0276645
N.B. These documents automatically identified may not have been verified by the study sponsor.