Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000052033
Ethics application status
Approved
Date submitted
15/01/2010
Date registered
18/01/2010
Date last updated
12/02/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Changes in troponin for diagnosis of acute myocardial infarction (AMI) in an emergency department (ED) population with chest pain.
Scientific title
In an Australian representative sample of patients presenting to an emergency department with chest pain, what delta troponin (TnI) value (percentage increase in TnI) has the greatest diagnostic accuracy to rule in acute myocardial infarction (AMI), either alone or in combination with the 99th percentile decision limit, at 0-2 hours and 0-6 hours after presentation using the Beckman Coulter Access AccuTnI assay?
Secondary ID [1] 1301 0
None
Secondary ID [2] 284081 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute coronary syndrome 256556 0
Condition category
Condition code
Cardiovascular 256724 256724 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
The current definition for AMI with the emphasis on the requirement for troponin elevations to be greater than the 99th percentile of a reference population in combination with a rising or falling pattern remains controversial. At present, there is no clearly defined, evidence based value for delta TnI. We aim to identify what delta TnI value (percentage increase in TnI) has the greatest diagnostic accuracy to rule in AMI, either alone or in combination with the 99th percentile decision limit, at 0-2 hours and 0-6 hours after presentation using the Beckman Coulter Access AccuTnI assay. Total period of observational trial is 1.5 years.
Intervention code [1] 255826 0
Not applicable
Comparator / control treatment
End point adjudication by cardiologists will define the clinical outcome for patients enrolled in the trial.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 257611 0
AMI as adjudicated by cardiologists as an endpoint.
Timepoint [1] 257611 0
Within 24 hours of presentation to ED
Secondary outcome [1] 262882 0
Alternative diagnosis with raised TnI - as adjudicated by cardiologists.
Timepoint [1] 262882 0
Within 24 hours of presentation to ED

Eligibility
Key inclusion criteria
Inclusion criteria include all patients who present to the emergency departmetn (ED)with at least 5 minutes of chest pain suggestive of acute coroanry syndrome (ACS). In accord with American Heart Association (AHA) guidelines, these will include the presence of acute chest, epigastric, neck, jaw or arm pain or discomfort or pressure or breathlessness without apparent non-cardiac source. More general/atypical symptoms (such as fatigue, nausea, vomiting, sweating and faintness) will not be used as inclusion criteria.

Patients who have chest discomfort and in whom the attending staff consider it necessary to perform an Electrocardiogram (ECG) for the assessment of possible ACS will be enrolled.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy
Patients under the age of 18 years old
Unable or unwilling to consent
Patients for whom follow-up will not be possible either due to lack of contact address or because they will be overseas.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/10/2008
Actual
29/10/2008
Date of last participant enrolment
Anticipated
20/10/2010
Actual
4/02/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
650
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256320 0
Charities/Societies/Foundations
Name [1] 256320 0
Queensland Emergency Medicine Research Foundation
Country [1] 256320 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Queensland Emergency Medicine Research Foundation QEMRF
Address
88 L'Estrange Tce
Kevin Grove
Queensland 4059
Country
Australia
Secondary sponsor category [1] 251637 0
None
Name [1] 251637 0
Address [1] 251637 0
Country [1] 251637 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258404 0
Human Research Ethics committee - Royal Brisbane and Womens Hospital
Ethics committee address [1] 258404 0
Butterfield St, Herston Queensland 4029
Ethics committee country [1] 258404 0
Australia
Date submitted for ethics approval [1] 258404 0
11/08/2008
Approval date [1] 258404 0
24/09/2008
Ethics approval number [1] 258404 0
2008/101

Summary
Brief summary
The current process for diagnosing heart attack (acute myocardial infarction; AMI) is to take multiple blood tests to measure cardiac troponin. The current definition for AMI requires troponin levels to be elevated (greater than the 99th percentile of a reference population) and to display a rising or falling pattern. However, this definition remains controversial as there is no clearly defined, evidence based data for how much the troponin level should change. We aim to identify what change in troponin value (percentage increase in troponin) has the greatest diagnostic accuracy for diagnosis of AMI. We will focus on the change in combination with the 99th percentile decision limit, at 0-2 hours and 0-6 hours after presentation using the Beckman Coulter Access AccuTnI assay.
Trial website
Trial related presentations / publications
Cullen L, Parsonage WA, Greenslade J, Lamanna A, Hammett CJ, Than M, Tate J, Kalinowski L, Ungerer JP, Chu K, Brown A. Delta troponin for the early diagnosis of AMI in emergency patients with chest pain. International Journal of Cardiology. 2013;168:2602-2608.
Public notes

Contacts
Principal investigator
Name 30710 0
A/Prof Louise Cullen
Address 30710 0
Royal Brisbane and Women's Hospital
Butterfield Street
HERSTON QLD 4006
Country 30710 0
Australia
Phone 30710 0
+61 7 3646 7901
Fax 30710 0
Email 30710 0
[email protected]
Contact person for public queries
Name 13957 0
Louise Cullen
Address 13957 0
Dept of Emergency Medicine
RBWH
Butterfiled St
Herston Queensland 4029
Country 13957 0
Australia
Phone 13957 0
+61 7 3636 7901
Fax 13957 0
Email 13957 0
[email protected]
Contact person for scientific queries
Name 4885 0
Louise Cullen
Address 4885 0
Dept of Emergency Medicine
RBWH
Butterfield St
Herston Queensland 4029
Country 4885 0
Australia
Phone 4885 0
+61 7 3636 7901
Fax 4885 0
Email 4885 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

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