Trial Review

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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
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)
Secondary ID [1] 301696 0
Nil
Universal Trial Number (UTN)
Trial acronym
GCOR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Artery Disease 318142 0
Percutaneous Coronary Intervention 318144 0
Heart Failure 318145 0
Permanent Pacemaker 318146 0
Implantable Cardioverter Defibrillator 318147 0
Cardiac Arrhythmia 318148 0
Condition category
Condition code
Cardiovascular 316166 316166 0 0
Coronary heart disease
Cardiovascular 316247 316247 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
10
Target follow-up type
Years
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.


Intervention code [1] 318090 0
Diagnosis / Prognosis
Comparator / control treatment
Not Applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 324775 0
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.
Timepoint [1] 324775 0
During hospital admission for clinically indicated procedure, and 30 days, 1, 2, 3, 4, 5 and 10 years post-procedure.
Primary outcome [2] 325086 0
Health outcomes (e.g. complications – haemorrhage, stroke, myocardial infarction, mortality) will be determined by follow-up telephone survey and data-linkage to medical records.
Timepoint [2] 325086 0
During hospital admission for clinically indicated procedure, and 30 days, 1, 2, 3, 4, 5 and 10 years post-procedure.
Secondary outcome [1] 385714 0
Patient Reported Outcome Measures e.g. change in health-related quality of life will be assessed using the EQ-5D-5L questionnaire,

Timepoint [1] 385714 0
During hospital admission for clinically indicated procedure and 1 year post-procedure.

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nil exclusion criteria.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
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.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
2/12/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50000
Accrual to date
17502
Final
Recruitment in Australia
Recruitment state(s)
QLD,SA,WA,VIC
Recruitment hospital [1] 17090 0
The Wesley Hospital - Auchenflower
Recruitment hospital [2] 17091 0
Greenslopes Private Hospital - Greenslopes
Recruitment hospital [3] 17092 0
Mount Hospital - Perth
Recruitment hospital [4] 17093 0
St Andrew's Hospital Inc - Adelaide
Recruitment hospital [5] 17094 0
Mater Private Hospital - South Brisbane
Recruitment hospital [6] 17095 0
Friendly Society Private Hospital - Bundaberg
Recruitment hospital [7] 17096 0
Warringal Private Hospital - Heidelberg
Recruitment hospital [8] 17097 0
The Valley Private Hospital - Mulgrave
Recruitment hospital [9] 17098 0
St John of God Hospital, Bunbury - Bunbury
Recruitment hospital [10] 17099 0
St John of God Hospital, Murdoch - Murdoch
Recruitment hospital [11] 17100 0
Calvary Wakefield Hospital - Adelaide
Recruitment postcode(s) [1] 30764 0
4066 - Auchenflower
Recruitment postcode(s) [2] 30765 0
4120 - Greenslopes
Recruitment postcode(s) [3] 30766 0
6000 - Perth
Recruitment postcode(s) [4] 30767 0
5000 - Adelaide
Recruitment postcode(s) [5] 30768 0
4101 - South Brisbane
Recruitment postcode(s) [6] 30769 0
4670 - Bundaberg
Recruitment postcode(s) [7] 30770 0
3084 - Heidelberg
Recruitment postcode(s) [8] 30771 0
3170 - Mulgrave
Recruitment postcode(s) [9] 30772 0
6230 - Bunbury
Recruitment postcode(s) [10] 30773 0
6150 - Murdoch

Funding & Sponsors
Funding source category [1] 306133 0
Commercial sector/Industry
Name [1] 306133 0
GenesisCare Cardiology
Country [1] 306133 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
GenesisCare Cardiology
Address
Building 1,The Mill
2 Huntley Street
Alexandria, New South Wales, 2015
Country
Australia
Secondary sponsor category [1] 306987 0
None
Name [1] 306987 0
Address [1] 306987 0
Country [1] 306987 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306350 0
Bellberry Human Research Ethics Committee
Ethics committee address [1] 306350 0
Ethics committee country [1] 306350 0
Australia
Date submitted for ethics approval [1] 306350 0
06/11/2008
Approval date [1] 306350 0
24/11/2008
Ethics approval number [1] 306350 0
2011-05-297

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

Contacts
Principal investigator
Name 103574 0
Prof David Eccleston
Address 103574 0
GenesisCare Bundoora
Health and Wellness Centre
Level 1, Suites 8-10
20 Scholar Drive
Bundoora, Victoria, 3083
Country 103574 0
Australia
Phone 103574 0
+61 3 8467 5900
Fax 103574 0
Email 103574 0
david.eccleston@genesiscare.com
Contact person for public queries
Name 103575 0
Sonya McColl
Address 103575 0
GenesisCare
Building 1, The Mill
2 Huntley Street
Alexandria, New South Wales, 2015
Country 103575 0
Australia
Phone 103575 0
+61 1800 951 885
Fax 103575 0
Email 103575 0
cardiology.research@genesiscare.com
Contact person for scientific queries
Name 103576 0
David Eccleston
Address 103576 0
GenesisCare Bundoora
Health and Wellness Centre
Level 1, Suites 8-10
20 Scholar Drive
Bundoora, Victoria, 3083
Country 103576 0
Australia
Phone 103576 0
+61 3 8467 5900
Fax 103576 0
Email 103576 0
david.eccleston@genesiscare.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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.


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
EmbaseSex Differences in Baseline Characteristics Do Not Predict Early Outcomes after Percutaneous Coronary Intervention: Results from the Australian GenesisCare Cardiovascular Outcomes Registry (GCOR).2022https://dx.doi.org/10.3390/jcm11041138
EmbaseLong-Term Outcomes of Contemporary Percutaneous Coronary Intervention with the Xience Drug-Eluting Stent: Results from a Multicentre Australian Registry.2023https://dx.doi.org/10.3390/jcm12010280
N.B. These documents automatically identified may not have been verified by the study sponsor.