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
ACTRN12612000990820
Ethics application status
Approved
Date submitted
12/09/2012
Date registered
13/09/2012
Date last updated
13/09/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Accelerated diagnostic process for selected low risk emergency department (ED) patients with chest pain
Scientific title
For selected low risk ED patients with non-traumatic chest pain, can an accelerated diagnostic protocol safely rule out acute coronary syndrome and major adverse cardiac events at 30 days
Secondary ID [1] 281217 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-traumatic chest pain 287407 0
Condition category
Condition code
Cardiovascular 287738 287738 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
Troponin I testing at ED presentation, 2 hours and 4 hours later performed on a sample of 5-10mls of venous blood
Intervention code [1] 285684 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 287974 0
Occurence of major adverse cardiac events defined as prevalent or incident myocardial infarction, death, cardiac arrest or serious arrhythmia or emergent revascularisation.
Timepoint [1] 287974 0
30 days
Secondary outcome [1] 299165 0
Predictive performance of GRACE Freedom from events score
Timepoint [1] 299165 0
30 days
Secondary outcome [2] 299166 0
Predictive performance of TIMI score for MI
Timepoint [2] 299166 0
ED diagnosis
Secondary outcome [3] 299167 0
Predictive performance of undetectable troponin level at ED presentation for MI
Timepoint [3] 299167 0
ED diagnosis

Eligibility
Key inclusion criteria
Adult patients presenting to ED with atraumatic chest pain of <24 hours duration
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Clear ECG evidence of ACS
No ECG or biomarker assay within 24 hours of chest pain
Clear alternative diagnosis at initial assessment
Decline consent to followup/ unavailable for followup

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/04/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285997 0
Hospital
Name [1] 285997 0
Western Health
Country [1] 285997 0
Australia
Primary sponsor type
Other
Name
Joseph Epstein Centre for Emergency Medicine Research at Western Health
Address
Sunshine Hospital Furlong Road St Albans VIC 3021
Country
Australia
Secondary sponsor category [1] 284814 0
None
Name [1] 284814 0
Address [1] 284814 0
Country [1] 284814 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288041 0
Western Hospital Low Risk Ethics Panel
Ethics committee address [1] 288041 0
Office for Research
Sunshine Hospital
Furlong Road
St Albans VIC 3021
Ethics committee country [1] 288041 0
Australia
Date submitted for ethics approval [1] 288041 0
Approval date [1] 288041 0
12/01/2012
Ethics approval number [1] 288041 0
HREC/11/WH/104

Summary
Brief summary
The assessment of patients presenting to Ed with chest pain aims to identify acute coronary artery syndrome (ACS) promptly and rule out ACS efficiently. This project aims to validate a 2 hour rapid rule out process and the GRACE Freedom for events score.
Trial website
None
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34703 0
Address 34703 0
Country 34703 0
Phone 34703 0
Fax 34703 0
Email 34703 0
Contact person for public queries
Name 17950 0
Anne-Maree Kelly
Address 17950 0
JECEMR
Sunshine Hospital
Furlong Road St Albans VIC 3021
Country 17950 0
Australia
Phone 17950 0
+61383958070
Fax 17950 0
Email 17950 0
[email protected]
Contact person for scientific queries
Name 8878 0
Anne-Maree Kelly
Address 8878 0
JECEMR
Sunshine Hospital
Furlong Road, St Albans VIC 3021
Country 8878 0
Australia
Phone 8878 0
+61383958070
Fax 8878 0
Email 8878 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
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseDoes undetectable troponin I at presentation using a contemporary sensitive assay rule out myocardial infarction? A cohort study.2015https://dx.doi.org/10.1136/emermed-2014-204442
Dimensions AIProspective external validation of an accelerated (2-h) acute coronary syndrome rule-out process using a contemporary troponin assay2014https://doi.org/10.1186/s12245-014-0042-3
Dimensions AIWhat is the Yield of Testing for Coronary Artery Disease after an Emergency Department Attendance with Chest Pain?2015https://doi.org/10.1016/j.hlc.2015.05.025
N.B. These documents automatically identified may not have been verified by the study sponsor.