Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001110976
Ethics application status
Approved
Date submitted
20/10/2011
Date registered
25/10/2011
Date last updated
25/10/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Australian & New Zealand Snapshot Acute Coronary Syndrome
Scientific title
Australian & New Zealand Snapshot Acute Coronary Syndrome - To explore the incidence, current management and acute outcomes of Acute Coronary Syndromes in a comprehensive sample of Australian and New Zealand hospitals and correlate this data with 12 month rates of death, recurrent myocardial infarction, stroke and cardiovascular re-admission.
Secondary ID [1] 273248 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Coronary Syndromes 279009 0
Condition category
Condition code
Cardiovascular 279194 279194 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 a retrospective registry which is designed to evaluate the contemporary patterns of care for patients who are admitted to hospital with an acute coronary syndrome (ACS) in Australia and New Zealand for a 2 week period between 14 - 27 August, 2012.

Information on the clinical characteristics, the in-hospital investigations and management patterns provided during 'usual care' will be compared to guidelines for recommended practice. The data will be collected from the medical records, entered onto an electronic case report form and transmitted to a central data repository at The George Institute in Sydney for analysis and reporting.

A study coordinator in each State will obtain follow-up data by contacting patients12 months after their admission to assess morbidity and mortality.
Intervention code [1] 269584 0
Not applicable
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 279831 0
Primary Objective:
To explore the incidence, current management and acute outcomes of Acute Coronary Syndromes in a comprehensive sample of Australian and New Zealand hospitals and correlate this with 12-month rates of death, recurrent myocardial infarction, stroke and cardiovascular readmission.
Timepoint [1] 279831 0
State coordinators will call patients at 1 year post-admission to obtain follow-up data which will be analysed using statistical methodoogies.
Secondary outcome [1] 294529 0
Secondary Objectives:
To evaluate access to timely evidence based therapies and to understand the impact of newer troponin assays on
ACS diagnosis and management
Timepoint [1] 294529 0
3 - 6 months post study timeframe
Aggregated data will be analysed using statistical methods.
Secondary outcome [2] 294567 0
To document patterns of interhospital transfer for the
delivery of invasive management
Timepoint [2] 294567 0
3 - 6 months post study timeframe
Aggregated data will be analysed using statistical methods
Secondary outcome [3] 294568 0
To evaluate the agreement between clinical diagnoses
and administrative hospital datasets
Timepoint [3] 294568 0
3 - 6 months post study timeframe
Aggregated data will be analysed using statistical methods

Eligibility
Key inclusion criteria
All adults over the age of 18 years presenting to hospital with Acute Coronary Syndromes throughout Australia and New Zealand within the specified timeframe.
Minimum age
18 Years
Maximum age
110 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nil

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
14/05/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
4000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 3917 0
New Zealand
State/province [1] 3917 0
Auckland

Funding & Sponsors
Funding source category [1] 270075 0
Government body
Name [1] 270075 0
Agency for Clinical Innovation Cardiac Network
Country [1] 270075 0
Australia
Funding source category [2] 284087 0
Government body
Name [2] 284087 0
South Australian Clinical Network
Country [2] 284087 0
Australia
Funding source category [3] 284088 0
Government body
Name [3] 284088 0
Cardiovascular Health Network
Country [3] 284088 0
Australia
Funding source category [4] 284089 0
Government body
Name [4] 284089 0
Victorian Cardiac Clinicial Network
Country [4] 284089 0
Australia
Funding source category [5] 284090 0
Government body
Name [5] 284090 0
State-wide Cardiac Clinical Network
Country [5] 284090 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Cardiac Society of Australia & New Zealand
Address
Macquarie Street
Sydney
NSW
2000
Country
Australia
Secondary sponsor category [1] 269041 0
Charities/Societies/Foundations
Name [1] 269041 0
National Heart Foundation
Address [1] 269041 0
80 William Street
East Sydney
NSW
2012
Country [1] 269041 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 272031 0
NSW Population & Health Services Research Ethics Committee: Cancer Institute NSW
Ethics committee address [1] 272031 0
Level 9
8 Central Avenue
Australian Technology Park
Eveleigh
Sydney
NSW
1435
Ethics committee country [1] 272031 0
Australia
Date submitted for ethics approval [1] 272031 0
30/05/2011
Approval date [1] 272031 0
15/08/2011
Ethics approval number [1] 272031 0
AU RED Reference: HREC/11/CIPHS/39

Summary
Brief summary
This project is a prospective registry which is designed to evaluate the contemporary patterns of care for patients who are admitted to hospital with an acute coronary syndrome (ACS) in Australia and New Zealand.

More than 400 centres that treat ACS patients will participate and the researchers expect to enrol approximately 4,000 patients over a 2 week period. The main objective of the registry is to provide a greater understanding of the management and health outcomes of patients across the full breadth of hospitals in both countries.

Information on the clinical characteristics, the in-hospital investigations and management patterns will be collected. This will be compared to guidelines for recommended practice. These data will inform future strategies to improve ACS care within Australia and New Zealand.
Trial website
Nil
Trial related presentations / publications
Nil
Public notes

Contacts
Principal investigator
Name 33291 0
Address 33291 0
Country 33291 0
Phone 33291 0
Fax 33291 0
Email 33291 0
Contact person for public queries
Name 16538 0
Bridie Carr
Address 16538 0
821 Pacific Highway
Chatswood
Sydney
NSW
2057
Country 16538 0
Australia
Phone 16538 0
+61 2 8644 2158
Fax 16538 0
Email 16538 0
[email protected]
Contact person for scientific queries
Name 7466 0
Professor David Brieger
Address 7466 0
Concord Hospital
Dept of Cardiology
Hospital Road
Concord
Sydney
NSW
2139
Country 7466 0
Australia
Phone 7466 0
+61 2 9767 6296
Fax 7466 0
Email 7466 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23201Study protocol   

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
3927Plain language summaryNo Of 478 sites that gained ethics approval to partic... [More Details]
4325Study results articleYes Acute coronary syndrome care across Australia and ... [More Details]

Documents added automatically
No additional documents have been identified.