Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000026527
Ethics application status
Approved
Date submitted
30/09/2014
Date registered
19/01/2015
Date last updated
22/02/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Clinical Features and Outcomes of Patients Undergoing Coronary Angiography in South Australian Public Hospitals - Coronary Angiogram Database of South Australia (CADOSA) Registry
Scientific title
Clinical Features and Outcomes of Patients Undergoing Coronary Angiography in South Australian Public Hospitals - Coronary Angiogram Database of South Australia (CADOSA) Quality Assurance Registry
Secondary ID [1] 285420 0
Nil
Universal Trial Number (UTN)
Trial acronym
CADOSA-Registry
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary artery disease 293168 0
Chest pain 293169 0
Coronary angiography 293170 0
Percutaneous coronary intervention 293171 0
Cardiac procedures registry 293172 0
Condition category
Condition code
Cardiovascular 293445 293445 0 0
Coronary heart disease
Public Health 293446 293446 0 0
Health service research

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
12
Target follow-up type
Months
Description of intervention(s) / exposure
The Coronary Angiogram Database of South Australia (CADOSA) is a registry of cardiac catheterisation procedures performed in the four public tertiary hospitals of South Australia (SA). This will be referred to as CADOSA-Registry. The CADOSA-Registry collects a standardised 8-page case report form (CRF) for all public coronary angiograms and percutaneous coronary interventions (PCI) performed in
the SA. The CRF is compatible with the American College of Cardiology National Cardiovascular Data Registry.

The purpose of this registry is a quality assurance measure to monitor the patients and the in-hospital care they receive undergoing angiography/PCI. This registry will also
evaluate future cardiac events (30-day & 12-month all-cause
mortality/myocardial infarction/cardiac re-admission) by analysis of administrative datasets and data linkage.
Since this is a clinical quality registry, there is no intervention or exposure for patients. The CADOSA-Registry has characteristics of clinical quality registries including:
-Collection of individual patient level data
-Collection of data from multiple sites
-Collection of treatment or care details of patients
-Collection outcome data
Intervention code [1] 290337 0
Not applicable
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 293265 0
To define the adverse event rate of patients undergoing coronary angiography/PCI as recorded in the Medical Record according to Data Specifications outlined by the American College of Cardiology National Cardiovascular Data Registry
Timepoint [1] 293265 0
During hospital admission for procedure
Secondary outcome [1] 310695 0
To assess the incidence of MACE (major adverse cardiac event) over 12 months in patients undergoing coronary angiography/PCI. MACE is defined as the occurrence of cardiovascular death, non-cardiovascular death, myocardial infarction, hospitalisation for unstable angina, hospitalisation for heart failure, transient ischaemic attack or stroke. Definition for events are as follows:
Cardiovascular Death: death resulting from an acute myocardial infarction, sudden cardiac death, death due to heart failure, death due to stroke, and death due to other cardiovascular causes.
Non-cardiovascular death: is defined as any death that is not thought to be due to a cardiovascular cause.
Myocardial Infarction: evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia.
In general, the diagnosis of MI requires the combination of:
*Evidence of myocardial necrosis (either changes in cardiac biomarkers or post-mortem pathological findings); and
*Supporting information derived from the clinical presentation, electrocardiographic changes, or the results of myocardial or coronary artery imaging.
Unstable angina requiring hospitalization: Symptoms of myocardial ischemia at rest (chest pain or equivalent) or an accelerating pattern of angina with frequent episodes associated with progressively decreased exercise capacity prompting an unscheduled visit to a healthcare facility and hospitalization (including chest pain observation units).
Heart failure requiring hospitalisation: an admission to an inpatient unit with clinical and physical signs of heart failure with the need for additional/increased therapy.
Transient Ischemic Attack: defined as a transient episode of neurological dysfunction caused by focal brain, spinal cord, or retinal ischemia, without acute infarction.
Stroke: defined as an acute episode of neurological dysfunction caused by focal or global brain, spinal cord, or retinal vascular injury.

The occurrence of MACE will be determined via data linkage to medical records and administrative datasets.
Timepoint [1] 310695 0
12 month post procedure
Secondary outcome [2] 310841 0
To assess performance measures of patients undergoing coronary angiography/PCI according to the recommended guidelines.

Performance measures are defined by the American College of Cardiology/American Heart Association (ACC/AHA), Reference: ACC/AHA 2008 performance measures for adults with ST-elevation and non-ST-elevation myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Performance Measures (Writing Committee to Develop Performance Measures for ST-Elevation and Non-ST-Elevation Myocardial Infarction), J Am Coll Cardiol. 2008 Dec 9;52(24):2046-99.

The Performance Measures are indicated in Table 3 of this publication, in brief these are:
1. Aspirin at arrival
2. Aspirin prescribed at discharge
3. Beta-blockers prescribed at discharge
4. Statin at discharge
5. Evaluation of LVSF
6. ACEI or ARB for LVSD
7. Time to fibrinolytic therapy
8. Time to PCI
9. Reperfusion therapy
10. Time from ED arrival at STEMI referral facility to ED
discharge from STEMI referral facility in patients transferred for PCI
11. Time from ED arrival at STEMI referral facility to PCI
at STEMI receiving facility among transferred patients
12. Adult smoking cessation advice/counseling
13. Cardiac rehabilitation patient referral from an inpatient
setting
T-1. LDL-C assessment
T-2. Excessive initial heparin dose
T-3. Excessive initial enoxaparin dose
T-4. Excessive initial abciximab dose
T-5. Excessive initial eptifibatide dose
T-6. Excessive initial tirofiban dose
T-7. Anticoagulant dosing protocol (structural measure)
T-8. Anticoagulant error tracking system (structural measure)
T-9. Clopidogrel at discharge.

Performances measures are assessed by collating and analysing the data collected from the CADOSA-Registry.
Timepoint [2] 310841 0
During hospital admission for procedure
Secondary outcome [3] 310842 0
To evaluate procedural appropriateness for coronary angiography/PCI according to appropriate use criteria.

Appropriate use criteria is defined by the American College of Cardiology for diagnostic catheterisation (ACCF/SCAI/AATS/AHA/ASE/ASNC/HFSA/HRS/SCCM/SCCT/SCMR/STS 2012 Appropriate Use Criteria for Diagnostic Catheterization, J Am Coll Cardiol. 2012;59(22):1-33)

and for PCI (ACCF/SCAI/STS/AATS/AHA/ASNC/HFSA/SCCT
2012 Appropriate Use Criteria for
Coronary Revascularization Focused Update, J Am Coll Cardiol. 2012 Feb 28;59(9):857-81).

These Criteria were developed in response to the need for the rational use of cardiovascular services, including imaging and invasive procedures. The Criteria provide a process to determine the appropriate use of cardiovascular procedures (cath & PCI) for selected patient indications. The Criteria rank appropriateness on a scale of 1-9, which are categorized into three groups with a respective median score being 1-3 (Inappropriate), 4-6 (Uncertain if inappropriate/appropriate) and 7-9 (Appropriate).

Procedure will have their appropriateness score calculated according to the syntax developed by the ACC. The appropriateness is determined by the data that is collected for the CADOSA-Registry.
Timepoint [3] 310842 0
During hospital admission for procedure

Eligibility
Key inclusion criteria
Undergoing coronary angiography/PCI at a South Australian teaching 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 - this registry captures all coronary angiography/PCI procedures performed in South Australian teaching hospitals

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Clinical characteristics and outcomes of patients will be reported as general descriptive statistics. Categorical variables will be presented as frequency values and proportions and continuous variables with a normal distribution are presented as mean/SD and median/IQR for nonparametric data.
Temporal trends in baseline variables will be examined with the linear-by-linear association test for categorical variables and by linear regression for continuous variables.
The cumulative incidence of mortality will be presented
by Kaplan-Meier event curves for the different years and cohorts. Cox regression analyses will be performed to adjust for covariates. The adjusted hazard ratio (HR) will be reported together with the corresponding 95% CI.
Logistic regression models will be used to adjust outcomes for differences across years and to estimate odds ratios (ORs) for adverse outcomes. Univariate variables with P < 0.2 will be included in multivariate model development.
All calculated P values will be two-sided, and P < 0.05 considered statistically significant.
In regards to power calculation/sample size determination, a registry typically requires several years of data collection before reliable comparisons between adverse events can be made. For example: to detect an increase in mortality from 1.5% to 2% between predefined groups (for example year 1 to year 2), at 90% power and 5% significance, a total sample size of 14,849 would be required. The CADOSA Registry is estimated to capture approximately 6,000 procedures each year.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/12/2011
Actual
1/12/2011
Date of last participant enrolment
Anticipated
31/12/2018
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
42000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 3025 0
The Queen Elizabeth Hospital - Woodville
Recruitment hospital [2] 3026 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [3] 3027 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment hospital [4] 3028 0
Flinders Medical Centre - Bedford Park

Funding & Sponsors
Funding source category [1] 290024 0
Charities/Societies/Foundations
Name [1] 290024 0
The South Australian Cardiovascular Research Development Program
Country [1] 290024 0
Australia
Primary sponsor type
Individual
Name
Prof John Beltrame
Address
The University of Adelaide
Discipline of Medicine
The Queen Elizabeth Hospital
28 Woodville Road
Woodville South
South Australia 5011
Country
Australia
Secondary sponsor category [1] 288715 0
None
Name [1] 288715 0
Address [1] 288715 0
Country [1] 288715 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291731 0
Human Research Ethics Committee (TQEH/LMH/MH)
Ethics committee address [1] 291731 0
Ethics committee country [1] 291731 0
Australia
Date submitted for ethics approval [1] 291731 0
Approval date [1] 291731 0
18/04/2011
Ethics approval number [1] 291731 0
2011012
Ethics committee name [2] 291732 0
Royal Adelaide Hospital Research Ethics Comittee
Ethics committee address [2] 291732 0
Ethics committee country [2] 291732 0
Australia
Date submitted for ethics approval [2] 291732 0
Approval date [2] 291732 0
17/08/2011
Ethics approval number [2] 291732 0
110816
Ethics committee name [3] 291733 0
Southern Adelaide Clinical Research Ethics Committee
Ethics committee address [3] 291733 0
Ethics committee country [3] 291733 0
Australia
Date submitted for ethics approval [3] 291733 0
Approval date [3] 291733 0
01/06/2011
Ethics approval number [3] 291733 0
232.11

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 271 271 0 0
/AnzctrAttachments/367180-CADOSA Data Form Version 1.4.pdf

Contacts
Principal investigator
Name 51778 0
Prof John Beltrame
Address 51778 0
The University of Adelaide
Discipline of Medicine
The Queen Elizabeth Hospital
28 Woodville Road
Woodville South
South Australia 5011
Country 51778 0
Australia
Phone 51778 0
+61 8 8222 6740
Fax 51778 0
Email 51778 0
[email protected]
Contact person for public queries
Name 51779 0
Rosanna Tavella
Address 51779 0
The University of Adelaide
Discipline of Medicine
The Queen Elizabeth Hospital
28 Woodville Road
Woodville South
South Australia 5011
Country 51779 0
Australia
Phone 51779 0
+61 8 81334011
Fax 51779 0
Email 51779 0
[email protected]
Contact person for scientific queries
Name 51780 0
Rosanna Tavella
Address 51780 0
The University of Adelaide
Discipline of Medicine
The Queen Elizabeth Hospital
28 Woodville Road
Woodville South
South Australia 5011
Country 51780 0
Australia
Phone 51780 0
+61 8 81334011
Fax 51780 0
Email 51780 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

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