Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000887673
Ethics application status
Approved
Date submitted
6/05/2013
Date registered
21/08/2014
Date last updated
13/07/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Australian Cooperative National Registry of Acute Coronary care, Guideline Adherence and Clinical Events
Scientific title
The Australian Cooperative National Registry of Acute Coronary care, Guideline Adherence and Clinical Events (CONCORDANCE) - a prospective observational registry of patients admitted to hospital with an acute coronary syndrome (ACS).
Secondary ID [1] 283636 0
NIL
Universal Trial Number (UTN)
Trial acronym
CONCORDANCE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Coronary Syndromes 286986 0
Condition category
Condition code
Cardiovascular 287320 287320 0 0
Coronary heart disease

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
12
Target follow-up type
Months
Description of intervention(s) / exposure
The Cooperative National Registry of Acute Coronary care, Guideline Adherence and Clinical Events (CONCORDANCE) is an Australian observational registry that describes the management and outcomes of patients with Acute Coronary Syndromes (ACS). Performance measures and patient outcomes are returned in real-time to participating hospitals benchmarked against the study aggregate for the purpose of reporting variation in care in-hospital. Patients are then followed for 12 months for readmission to hospital for cardiovascular disease, medication compliance and access to secondary prevention.
Intervention code [1] 285341 0
Not applicable
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289492 0
The primary purpose of the registry is to provide data to health care providers and hospitals to characterise existing and evolving practice patterns, delivery of care, and resource utilization in the management of ACS across Australia. For example the following process measures are provided;
Door to balloon time for patients with ST elevation MI receiving PCI; Door to needle time for patients with STEMI receiving fibrinolysis and proportion of high risk non-ST elevation ACS patients receiving in hospital angiography.
Timepoint [1] 289492 0
These data are provided to clinicians as on-line real-time performance measure reports (key performance indicators -KPIs) benchmarked against national aggregate data.
Secondary outcome [1] 302606 0
To document and inform the appropriate use of medications in the Australian ACS population, including higher risk subsets not well represented in clinical trials. For example these data are provided to clinicians as on-line real-time performance measure reports (key performance indicators -KPIs) benchmarked against national aggregate data. Proportion of STEMI and high risk non-ST elevation ACS patients receiving in hospital clopidogrel; proportion of high risk non-ST elevation ACS receiving glycoprotein GPIIb/IIIa antagonist therapy; proportion of ACS patients discharged on beta-blocker; proportion of ACS patients discharged on ACE-inhibitor or Angiotensin Receptor Blocker; proportion of ACS patients discharged on aspirin and proportion of ACS patients discharged on statin therapy.
Timepoint [1] 302606 0
These data are provided to clinicians as on-line real-time performance measure reports (key performance indicators -KPIs) benchmarked against national aggregate data.

Eligibility
Key inclusion criteria
All patients must have symptoms of an ACS plus one of the following: ECG changes, elevated enzymes, previous history of CAD, new documentation of CAD or two features of high risk ACS.
Patients are eligible if they present to hospital with symptoms felt to be consistent with acute cardiac ischaemia for >10mins within 24 hours of presentation to hospital plus one of the following: ECG changes; elevated enzymes; documentation of CAD or documentation of 2 or more high risk features for CAD.

ECG changes:
- transient ST segment elevation of 0.5mm in two or more contiguous leads;
- ST segment depression of 0.5mm in two or more contiguous leads
- new T wave inversion of 1 mm in two or more contiguous leads
- new Q waves (1/3 height of R wave or >0.04 seconds)
- new R wave > S wave in lead V1 (posterior MI)
- new left bundle branch block

Increase in cardiac enzymes:
- increase in troponin T above the upper limit of normal;
- increase in troponin I above the upper limit of normal;
- CK-MB 2x upper limit of the hospitals normal range or if there is no CK-MB available, then total CK greater than the upper limit of normal.

Documentation of Coronary Artery Disease:
- history of MI, angina, congestive cardiac failure due to ischaemia or resuscitated sudden cardiac death;
- history of, or new positive stress test with or without imaging;
- prior or new, cardiac catheterisation documenting coronary artery disease;
- prior, or new percutaneous coronary artery intervention or coronary artery bypass graft surgery.

At least 2 of the following High Risk features:
- haemodynamic compromise (BP<90 and HR >100)
- left ventricular systolic dysfunction (LVEF<0.40);
- presence of known diabetes
- documentation of chronic kidney disease (estimated GFR <60mls/min
Minimum age
18 Years
Maximum age
120 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The qualifying acute coronary syndrome must not be precipitated or accompanied by a co-morbidity such as trauma or major bleeding and patients already hospitalised for any reason when the ACS develops are not eligible for enrolment in CONCORDANCE.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Ongoing data collection from representative hospitals to facilitate spatial and temporal analysis of change in practice and the application of treatment modalities in the real world setting. Data on 1,000 patients per year will allow for robust determination of associations between changes in practice patterns over time and outcomes

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
4/05/2009
Actual
4/05/2009
Date of last participant enrolment
Anticipated
31/12/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
8000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 1807 0
Bankstown-Lidcombe Hospital - Bankstown
Recruitment hospital [2] 1808 0
Bathurst Base Hospital - Bathurst
Recruitment hospital [3] 1809 0
Campbelltown Hospital - Campbelltown
Recruitment hospital [4] 1810 0
Coffs Harbour Base Hospital - Coffs Harbour
Recruitment hospital [5] 1811 0
Concord Repatriation Hospital - Concord
Recruitment hospital [6] 1812 0
Dubbo Base Hospital - Dubbo
Recruitment hospital [7] 1813 0
John Hunter Hospital Royal Newcastle Centre - New Lambton
Recruitment hospital [8] 1814 0
Lismore Base Hospital - Lismore
Recruitment hospital [9] 1815 0
Liverpool Hospital - Liverpool
Recruitment hospital [10] 1816 0
Nepean Hospital - Kingswood
Recruitment hospital [11] 1817 0
Port Macquarie Base Hospital - Port Macquarie
Recruitment hospital [12] 1818 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [13] 1819 0
Shoalhaven Hospital - Nowra
Recruitment hospital [14] 1821 0
Westmead Hospital - Westmead
Recruitment hospital [15] 1822 0
Wollongong Hospital - Wollongong
Recruitment hospital [16] 1823 0
The Canberra Hospital - Garran
Recruitment hospital [17] 1824 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [18] 1825 0
The Alfred - Prahran
Recruitment hospital [19] 1826 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [20] 1827 0
Bairnsdale Regional Health Service - Bairnsdale
Recruitment hospital [21] 1828 0
Box Hill Hospital - Box Hill
Recruitment hospital [22] 1829 0
Barwon Health - Geelong Hospital campus - Geelong
Recruitment hospital [23] 1830 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [24] 1831 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment hospital [25] 1832 0
Gold Coast Hospital - Southport
Recruitment hospital [26] 1833 0
The Prince Charles Hospital - Chermside
Recruitment hospital [27] 1834 0
Toowoomba Hospital - Toowoomba
Recruitment hospital [28] 1835 0
The Townsville Hospital - Douglas
Recruitment hospital [29] 1836 0
Alice Springs Hospital - Alice Springs
Recruitment hospital [30] 1837 0
Royal Darwin Hospital - Tiwi
Recruitment hospital [31] 1838 0
Royal Perth Hospital - Perth
Recruitment hospital [32] 1839 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [33] 2887 0
Maitland Hospital - Maitland
Recruitment hospital [34] 2888 0
Orange Health Service - Orange
Recruitment hospital [35] 2889 0
Nambour General Hospital - Nambour
Recruitment hospital [36] 2890 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [37] 2891 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment hospital [38] 2892 0
Modbury Hospital - Modbury
Recruitment hospital [39] 2893 0
The Queen Elizabeth Hospital - Woodville
Recruitment hospital [40] 2894 0
The Northern Hospital - Epping
Recruitment hospital [41] 2895 0
Royal Hobart Hospital - Hobart
Recruitment hospital [42] 2896 0
Launceston General Hospital - Launceston
Recruitment hospital [43] 6161 0
St George Hospital - Kogarah
Recruitment postcode(s) [1] 7625 0
2139 - Concord Repatriation Hospital
Recruitment postcode(s) [2] 8579 0
2200 - Bankstown
Recruitment postcode(s) [3] 8580 0
2795 - Bathurst West
Recruitment postcode(s) [4] 8582 0
2560 - Campbelltown
Recruitment postcode(s) [5] 8583 0
2450 - Coffs Harbour
Recruitment postcode(s) [6] 8584 0
2830 - Dubbo
Recruitment postcode(s) [7] 8585 0
2305 - New Lambton
Recruitment postcode(s) [8] 8586 0
2480 - Lismore
Recruitment postcode(s) [9] 8587 0
2170 - Liverpool
Recruitment postcode(s) [10] 8588 0
2320 - Maitland
Recruitment postcode(s) [11] 8589 0
2750 - Penrith
Recruitment postcode(s) [12] 8590 0
2800 - Orange
Recruitment postcode(s) [13] 8591 0
2444 - Port Macquarie
Recruitment postcode(s) [14] 8592 0
2050 - Missenden Road
Recruitment postcode(s) [15] 8593 0
2541 - Nowra
Recruitment postcode(s) [16] 8594 0
2145 - Westmead
Recruitment postcode(s) [17] 8595 0
2500 - Wollongong
Recruitment postcode(s) [18] 8596 0
2605 - Garran
Recruitment postcode(s) [19] 8597 0
0870 - Alice Springs
Recruitment postcode(s) [20] 8598 0
0810 - Tiwi
Recruitment postcode(s) [21] 8599 0
4215 - Southport
Recruitment postcode(s) [22] 8600 0
4560 - Nambour
Recruitment postcode(s) [23] 8601 0
4032 - Chermside
Recruitment postcode(s) [24] 8602 0
4029 - Royal Brisbane Hospital
Recruitment postcode(s) [25] 8604 0
4350 - Toowoomba
Recruitment postcode(s) [26] 8605 0
4810 - Townsville
Recruitment postcode(s) [27] 8606 0
5042 - Bedford Park
Recruitment postcode(s) [28] 8607 0
5112 - Elizabeth Vale
Recruitment postcode(s) [29] 8608 0
5092 - Modbury
Recruitment postcode(s) [30] 8609 0
5011 - Woodville South
Recruitment postcode(s) [31] 8610 0
3004 - Melbourne
Recruitment postcode(s) [32] 8611 0
3084 - Heidelberg
Recruitment postcode(s) [33] 8612 0
3875 - Bairnsdale
Recruitment postcode(s) [34] 8613 0
3128 - Box Hill
Recruitment postcode(s) [35] 8614 0
3220 - Geelong
Recruitment postcode(s) [36] 8615 0
3076 - Epping
Recruitment postcode(s) [37] 8616 0
3065 - Fitzroy
Recruitment postcode(s) [38] 8617 0
3168 - Clayton
Recruitment postcode(s) [39] 8618 0
6009 - Nedlands
Recruitment postcode(s) [40] 8619 0
6847 - Perth
Recruitment postcode(s) [41] 8620 0
7000 - Hobart
Recruitment postcode(s) [42] 8621 0
7250 - Launceston
Recruitment postcode(s) [43] 13598 0
2622 - St George

Funding & Sponsors
Funding source category [1] 287213 0
Government body
Name [1] 287213 0
The registry is funded by unrestricted grants from the Heart Foundation of Australia and pharmaceutical and non-pharmaceutical collaborative groups to Sydney Local Health District, Concord Hospital (Sponsor)
Country [1] 287213 0
Australia
Funding source category [2] 288398 0
Charities/Societies/Foundations
Name [2] 288398 0
Heart Foundation of Australia
Country [2] 288398 0
Australia
Funding source category [3] 288399 0
Commercial sector/Industry
Name [3] 288399 0
Sanofi
Country [3] 288399 0
Australia
Funding source category [4] 288400 0
Commercial sector/Industry
Name [4] 288400 0
Astra Zeneca
Country [4] 288400 0
Australia
Funding source category [5] 288401 0
Commercial sector/Industry
Name [5] 288401 0
Boehringer Ingelheim Pty Limited
Country [5] 288401 0
Australia
Funding source category [6] 288402 0
Commercial sector/Industry
Name [6] 288402 0
Eli Lilly
Country [6] 288402 0
Australia
Primary sponsor type
Government body
Name
Sydney Local Health District
Address
MIssenden Rd
Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 287102 0
Charities/Societies/Foundations
Name [1] 287102 0
The ANZAC Research Institute
Address [1] 287102 0
Hospital Rd
Concord NSW 2139
Country [1] 287102 0
Australia
Other collaborator category [1] 277716 0
Charities/Societies/Foundations
Name [1] 277716 0
The Cardiovascular Division of the George Institute for International Health
Address [1] 277716 0
Missenden Rd
Camperdown NSW 2050
Country [1] 277716 0
Australia
Other collaborator category [2] 277717 0
University
Name [2] 277717 0
The Centre for Outcomes Research at The University of Massachusetts Medical School
Address [2] 277717 0
1 Innovation Drive, Suite 110, Worcester, MA 01605
Country [2] 277717 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289202 0
SLHD Human Research Ethics Committee-Concord Hospital
Ethics committee address [1] 289202 0
Ethics committee country [1] 289202 0
Australia
Date submitted for ethics approval [1] 289202 0
18/09/2008
Approval date [1] 289202 0
28/11/2008
Ethics approval number [1] 289202 0
CH62/6/2008-141

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34482 0
Prof David Brieger
Address 34482 0
Cardiology Department
Concord Hospital
Hospital Rd
Concord NSW 2139
Country 34482 0
Australia
Phone 34482 0
+61 2 97676296
Fax 34482 0
Email 34482 0
[email protected]
Contact person for public queries
Name 17729 0
Victoria Miler
Address 17729 0
Cardiology Department
Concord Hospital
Hospital Rd
Concord NSW 2139
Country 17729 0
Australia
Phone 17729 0
+61 2 97675539
Fax 17729 0
Email 17729 0
[email protected]
Contact person for scientific queries
Name 8657 0
David Brieger
Address 8657 0
Cardiology Department
Concord Hospital
Hospital Rd
Concord NSW 2139
Country 8657 0
Australia
Phone 8657 0
+61 2 97676296
Fax 8657 0
Email 8657 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
EmbaseFrailty and outcomes after myocardial infarction: Insights from the CONCORDANCE registry.2018https://dx.doi.org/10.1161/JAHA.118.009859
EmbaseST-Elevation Acute Myocardial Infarction in Australia-Temporal Trends in Patient Management and Outcomes 1999-2016.2019https://dx.doi.org/10.1016/j.hlc.2018.05.191
N.B. These documents automatically identified may not have been verified by the study sponsor.