Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000053022
Ethics application status
Approved
Date submitted
15/01/2010
Date registered
18/01/2010
Date last updated
10/02/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
The QUeensland Accelerated Risk Trial (QUART): Accelerated pathways in the assessment of suspected acute coronary syndrome in the Emergency Department.
Scientific title
In patients presenting to the emergency department with potential acute coroanry syndrome (ACS) is there a difference in the change in troponin (absolute and rate) and a traditional mulitmarker approach with risk stratification tools in excluding significant coronary artery disease?
Secondary ID [1] 1300 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute coronary syndromes 256554 0
Condition category
Condition code
Cardiovascular 256722 256722 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
This study is designed to prospectively validate that an ‘accelerated chest pain algorithm’ involving blood levels of Troponin I, creatine-kinase MB fraction (CK-MB), and myoglobin or ‘delta’ troponin measurements over a 2 hour time period from presentation with a risk stratification process allows ealry futher testing or discharge of patients with intermediate risk for acute coronary syndrome (ACS) presenting to the Emergency department (ED). These results will be used to develop a pathway for investigation of pateints with potential acute coronary syndrome (ACS).

We will focus on delta troponin, as well as myoglobin, and CK-MB combinations and look at absolute change in biomarker levels and rates of change to identify the population at risk for ACS.
The overall duration will be ~ 2years.
Intervention code [1] 255824 0
Not applicable
Comparator / control treatment
Current practice for identification of high risk patients involves a risk stratification process of serial electrocardiograms (ECGs), and Troponin I (TnI) testing 0 and 6hr post-presentation. This will continue to be performed, and patients care will be based on CURRENT practice.
Control group
Active

Outcomes
Primary outcome [1] 257609 0
cardiac death as adjudicated by cardiologists
Timepoint [1] 257609 0
45 days from index presentation
Primary outcome [2] 257638 0
acute myocardial infarction as adjudicated by cardiologists
Timepoint [2] 257638 0
45 days from index presentation
Primary outcome [3] 257639 0
revascularization procedure as adjudicated by cardiologists
Timepoint [3] 257639 0
45 days from index presentation
Secondary outcome [1] 262880 0
acute coronary syndrome as adjudicated by cardiologists
Timepoint [1] 262880 0
45 days from index presentation
Secondary outcome [2] 262909 0
All cause mortalityas adjudicated by cardiologists
Timepoint [2] 262909 0
45 days from index presentation

Eligibility
Key inclusion criteria
Inclusion criteria include all patients who present to the ED with at least 5 minutes of chest pain suggestive of 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
20/10/2008
Actual
4/02/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
1000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256318 0
Charities/Societies/Foundations
Name [1] 256318 0
Queensland Emergency Medicine Research Foundation
Country [1] 256318 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Queensland Emergency Medicine Research Foundation
Address
88 L'Estrange tce,
Kelvin Grove, Queensland 4059
Country
Australia
Secondary sponsor category [1] 251635 0
None
Name [1] 251635 0
Address [1] 251635 0
Country [1] 251635 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258402 0
Human research ethics commmitee (HREC) - Royal Brisbane and Women's Hospital
Ethics committee address [1] 258402 0
Butterfield St,
Herston Queensland 4029
Ethics committee country [1] 258402 0
Australia
Date submitted for ethics approval [1] 258402 0
11/08/2008
Approval date [1] 258402 0
24/09/2008
Ethics approval number [1] 258402 0
2008/101

Summary
Brief summary
This study examines whether patients presenting to emergency with chest pain can be managed more rapidly than current standard care. The current process involves blood tests over 6-24 hours. The study study examines the safety of an ‘accelerated chest pain algorithm’ . That is whether combining the results of blood tests such as Troponin I, creatine-kinase MB fraction (CK-MB), and myoglobin over a 2 hour time period from presentation with a risk stratification process allows early futher testing or discharge of patients with potential acute coronary syndrome (ACS). These results will be used to develop a pathway for investigation of pateints with potential acute coronary syndrome (ACS) in the Emergency Department.
Trial website
Trial related presentations / publications
Cullen L, Parsonage WA, Greenslade J, Lamanna A, Hammett CJ, Than M, Ungerer JP, Chu K, O'Kane S, Brown AF. Comparison of early biomarker strategies with the Heart Foundation of Australia/Cardiac Society of Australia and New Zealand guidelines for risk stratification of emergency department patients with chest pain. Emerg Med Australas. 2012;24:595-603.
Public notes

Contacts
Principal investigator
Name 30708 0
A/Prof Louise Cullen
Address 30708 0
Department of Emergency Medicine, Royal Brisbane and Women's Hospital, Butterfield Street, HERSTON QLD 4029
Country 30708 0
Australia
Phone 30708 0
+617 36467901
Fax 30708 0
Email 30708 0
[email protected]
Contact person for public queries
Name 13955 0
A/Prof Dr Louise Cullen
Address 13955 0
Dept of Emergency Medicine,
Royal Brisbane and Women's Hospital
Butterfiled St
Herston Queensland 4029
Country 13955 0
Australia
Phone 13955 0
+61 7 3636 7901
Fax 13955 0
Email 13955 0
[email protected]
Contact person for scientific queries
Name 4883 0
A/Prof Dr Louise Cullen
Address 4883 0
Dept of Emergency Medicine,
Royal Brisbane and Women's Hospital
Butterfield St
Herston Queensland 4029
Country 4883 0
Australia
Phone 4883 0
+61 7 3636 7901
Fax 4883 0
Email 4883 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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