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Trial registered on ANZCTR
Registration number
ACTRN12620000899943
Ethics application status
Approved
Date submitted
17/07/2020
Date registered
11/09/2020
Date last updated
11/09/2020
Date data sharing statement initially provided
11/09/2020
Type of registration
Retrospectively registered
Titles & IDs
Public title
GenesisCare Cardiovascular Outcomes Registry of Australian Percutaneous Coronary Intervention and Cardiac Implantable Electronic Device Patients
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Scientific title
A clinical prospective registry of Percutaneous Coronary Intervention and Cardiac Implantable Electronic Device patients treated at GenesisCare affiliated hospitals in Australia (A168/08)
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Secondary ID [1]
301696
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Nil
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Universal Trial Number (UTN)
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Trial acronym
GCOR
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Coronary Artery Disease
318142
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Percutaneous Coronary Intervention
318144
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Heart Failure
318145
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Permanent Pacemaker
318146
0
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Implantable Cardioverter Defibrillator
318147
0
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Cardiac Arrhythmia
318148
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Condition category
Condition code
Cardiovascular
316166
316166
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0
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Coronary heart disease
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Cardiovascular
316247
316247
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0
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Other cardiovascular diseases
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Intervention/exposure
Study type
Observational
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Patient registry
True
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Target follow-up duration
10
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Target follow-up type
Years
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Description of intervention(s) / exposure
The GenesisCare Cardiovascular Outcomes Registry (GCOR) is a clinical quality register established to collect information on all patients undergoing Percutaneous Coronary Intervention (PCI) or Cardiac Implantable Electronic Device (CIED) implantation at GenesisCare affiliated hospital sites across Australia.
Clinical Research Assistants from GenesisCare will collect information pertaining to the participants medical history, demographic and procedural data, medication use, and follow-up cardiac health outcomes utilising data-linkage to medical records and from participants by phone.
Clinical Research Assistants will contact participants by phone at 30 days, 1, 2, 3, 4, 5 and 10 years post-procedure, to briefly obtain information about their heart health. Participants will be asked about any new cardiac symptoms, EQ-5D-5L Quality of Life questionnaire, any further procedural and/or hospital admissions that may have occurred and medication use.
Performance and outcome measure feedback will be provided to participating hospitals and health care providers to allow benchmarking against national and international results, although this data will be de-identified in reports.
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Intervention code [1]
318090
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Diagnosis / Prognosis
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Comparator / control treatment
Not Applicable
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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The primary purpose of this registry is to improve patient care by evaluating care delivered through PCI and CIED implantations and provide significant real-world data on patients, procedures, treatments and outcomes to health care providers. For example, the following outcome measures are collated;
Assessment of post-procedure complications, including hospital readmission rates, will be determined by follow-up telephone survey and data-linkage to medical records.
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Assessment method [1]
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Timepoint [1]
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During hospital admission for clinically indicated procedure, and 30 days, 1, 2, 3, 4, 5 and 10 years post-procedure.
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Primary outcome [2]
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Health outcomes (e.g. complications – haemorrhage, stroke, myocardial infarction, mortality) will be determined by follow-up telephone survey and data-linkage to medical records.
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Assessment method [2]
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Timepoint [2]
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During hospital admission for clinically indicated procedure, and 30 days, 1, 2, 3, 4, 5 and 10 years post-procedure.
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Secondary outcome [1]
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Patient Reported Outcome Measures e.g. change in health-related quality of life will be assessed using the EQ-5D-5L questionnaire,
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Assessment method [1]
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Timepoint [1]
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During hospital admission for clinically indicated procedure and 1 year post-procedure.
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Eligibility
Key inclusion criteria
This registry will include all patients from GenesisCare Cardiology practices who are undergoing Percutaneous Coronary Intervention (PCI) or Cardiac Implantable Electronic Device (CIED) implantation at a GenesisCare Cardiology affiliated hospital.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Nil exclusion criteria.
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Study design
Purpose
Natural history
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Duration
Longitudinal
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Selection
Defined population
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Timing
Prospective
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Statistical methods / analysis
De-identified data sets will be reviewed systematically for duplicates, missing data and errors.
All personal health information collected during routine clinical review will be entered by designated clinical staff into the GenesisCare Cardiology EMR. The EMR has internal quality checks including mandatory fields, and error checking such as logic and out of range checks, and by generating appropriate error messages, allow the data to be confirmed or corrected online by the staff.
Internal audits to ensure completeness and accuracy will be undertaken by GenesisCare at regular intervals.
All statistical analysis plans will consider the research question/hypothesis, the nature of the data to be collected and the appropriate analytic approaches to address them.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
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Actual
2/12/2008
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
50000
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Accrual to date
17502
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Final
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Recruitment in Australia
Recruitment state(s)
QLD,SA,WA,VIC
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Recruitment hospital [1]
17090
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The Wesley Hospital - Auchenflower
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Recruitment hospital [2]
17091
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Greenslopes Private Hospital - Greenslopes
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Recruitment hospital [3]
17092
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Mount Hospital - Perth
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Recruitment hospital [4]
17093
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St Andrew's Hospital Inc - Adelaide
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Recruitment hospital [5]
17094
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Mater Private Hospital - South Brisbane
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Recruitment hospital [6]
17095
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Friendly Society Private Hospital - Bundaberg
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Recruitment hospital [7]
17096
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Warringal Private Hospital - Heidelberg
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Recruitment hospital [8]
17097
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The Valley Private Hospital - Mulgrave
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Recruitment hospital [9]
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St John of God Hospital, Bunbury - Bunbury
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Recruitment hospital [10]
17099
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St John of God Hospital, Murdoch - Murdoch
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Recruitment hospital [11]
17100
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Calvary Wakefield Hospital - Adelaide
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Recruitment postcode(s) [1]
30764
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4066 - Auchenflower
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Recruitment postcode(s) [2]
30765
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4120 - Greenslopes
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Recruitment postcode(s) [3]
30766
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6000 - Perth
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Recruitment postcode(s) [4]
30767
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5000 - Adelaide
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Recruitment postcode(s) [5]
30768
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4101 - South Brisbane
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Recruitment postcode(s) [6]
30769
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4670 - Bundaberg
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Recruitment postcode(s) [7]
30770
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3084 - Heidelberg
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Recruitment postcode(s) [8]
30771
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3170 - Mulgrave
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Recruitment postcode(s) [9]
30772
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6230 - Bunbury
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Recruitment postcode(s) [10]
30773
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6150 - Murdoch
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Funding & Sponsors
Funding source category [1]
306133
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Commercial sector/Industry
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Name [1]
306133
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GenesisCare Cardiology
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Address [1]
306133
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Building 1,The Mill
2 Huntley Street
Alexandria, New South Wales, 2015
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Country [1]
306133
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Australia
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Primary sponsor type
Commercial sector/Industry
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Name
GenesisCare Cardiology
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Address
Building 1,The Mill
2 Huntley Street
Alexandria, New South Wales, 2015
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
306987
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Address [1]
306987
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Country [1]
306987
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
306350
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Bellberry Human Research Ethics Committee
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Ethics committee address [1]
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123 Glen Osmond Road
Eastwood, South Australia, 5063
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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06/11/2008
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Approval date [1]
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24/11/2008
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Ethics approval number [1]
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2011-05-297
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Summary
Brief summary
The GenesisCare Outcomes Registry (GCOR) was established in November 2008 and is designed to improve patient care and outcomes through greater understanding of events, treatment and outcomes. The Registry collects detailed clinical, procedural and outcomes data on GenesisCare patients undergoing Percutaneous Coronary Intervention (PCI) or Cardiac Implantable Electronic Device (CIED) implantations.
In order to improve the quality care and guideline compliance in Australia with National Outcome Registries, the registry aims to capture 100% of GenesisCare patients to monitor and benchmark compliance, care and outcomes, provide a national set of risk adjusted, consumer-focused and current clinical performance indicators to reflect clinical variations and patient outcomes. The registry will also inform research and the scientific community on coronary disease through publications/presentations, support evidence-based therapies, create efficiencies in healthcare and contribute to reducing mortality and morbidity.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof David Eccleston
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Address
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GenesisCare Bundoora
Health and Wellness Centre
Level 1, Suites 8-10
20 Scholar Drive
Bundoora, Victoria, 3083
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Country
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Australia
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Phone
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+61 3 8467 5900
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Ms Sonya McColl
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Address
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GenesisCare
Building 1, The Mill
2 Huntley Street
Alexandria, New South Wales, 2015
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Country
103575
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Australia
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Phone
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+61 1800 951 885
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Fax
103575
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Email
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[email protected]
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Contact person for scientific queries
Name
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Prof David Eccleston
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Address
103576
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GenesisCare Bundoora
Health and Wellness Centre
Level 1, Suites 8-10
20 Scholar Drive
Bundoora, Victoria, 3083
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Country
103576
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Australia
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Phone
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+61 3 8467 5900
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Fax
103576
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Any report published will only include aggregated data and will not include individual participants data or any other form of identification.
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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
Source
Title
Year of Publication
DOI
Embase
Sex Differences in Baseline Characteristics Do Not Predict Early Outcomes after Percutaneous Coronary Intervention: Results from the Australian GenesisCare Cardiovascular Outcomes Registry (GCOR).
2022
https://dx.doi.org/10.3390/jcm11041138
Embase
Long-Term Outcomes of Contemporary Percutaneous Coronary Intervention with the Xience Drug-Eluting Stent: Results from a Multicentre Australian Registry.
2023
https://dx.doi.org/10.3390/jcm12010280
N.B. These documents automatically identified may not have been verified by the study sponsor.
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