Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001096640
Ethics application status
Approved
Date submitted
25/09/2014
Date registered
16/10/2014
Date last updated
22/02/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Self Reported Health Outcomes over 12 months of Patients Undergoing Coronary Angiography for the Evaluation of Chest Pain in South Australia - Coronary Angiogram Database of South Australia (CADOSA) Outcomes Study
Scientific title
Coronary Angiogram Database of South Australia (CADOSA) Outcomes Study - Health Outcomes Follow-up of Patients Undergoing Coronary Angiography for the Evaluation of Chest Pain
Secondary ID [1] 285400 0
Nil
Universal Trial Number (UTN)
Trial acronym
CADOSA-Outcomes
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary artery disease 293140 0
Quality of life 293141 0
Depression 293142 0
Coronary angiography 293143 0
Chest pain 293144 0
Percutaneous coronary intervention 293145 0
Condition category
Condition code
Cardiovascular 293409 293409 0 0
Coronary heart disease
Public Health 293410 293410 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 the CADOSA-Quality Assurance (or CADOSA-QA) registry and is distinguished from the research protocol referred to as the CADOSA Outcomes study (CADOSA-Outcomes). The CADOSA-QA 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.

The CADOSA-Outcomes Study will compliment the CADOSA-QA Registry by obtaining 12-month health outcomes in a subpopulation of the CADOSA cohort. Patients participating in this study will be provided with a patient information sheet during their admission for the procedure and consented for follow-up contact. Consenting patients will complete a health status assessment via administration of quality of life questionnaires (QoL) in hospital. Patients will then be contacted via phone by the study staff at 1 and 12 months following angiography. The will be asked several questions relating to their cardiac status and medications changes, as well as being asked several quality of life questionnaires over the phone. The QoL questionnaires will include: Seattle Angina Questionnaire (SAQ), EuroQol 5D (EQ-5D), Patient Health Questionnaire 9 (PHQ-9) and Short Form-36 (SF-36).
Intervention code [1] 290317 0
Not applicable
Comparator / control treatment
There is no comparator/control treatment in this study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 293237 0
Self reported angina status assessed by the Seattle Angina Questionnaire
Timepoint [1] 293237 0
12 months post coronary angiography procedure
Primary outcome [2] 293238 0
Self reported qualify of life assessed by the Short Form-36 and EuorQol-5D
Timepoint [2] 293238 0
12 months post coronary angiography procedure
Primary outcome [3] 293264 0
Self reported depression status assessed by the Patient Health Questionnaire 9.
Timepoint [3] 293264 0
12 months post coronary angiography procedure
Secondary outcome [1] 310653 0
Frequency of MACE (major adverse cardiac events) assessed by review of hospital administrative databases.
Timepoint [1] 310653 0
12 months post coronary angiography procedure

Eligibility
Key inclusion criteria
Undergoing coronary angiography/PCI at a South Australian Teaching hospital for the investigation of chest pain
AND
Able to complete quality of life questionnaires in English
AND
Able to be followed up for 12 months post procedure
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to complete QoL questionnaires in English
Unable to be followed up for 12 months post procedure

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Clinical characteristics and health status outcomes 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 non-parametric data. 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. In regards to sample size determination, this was based on Seattle Angina Questionnaire (SAQ) scores. The treatment satisfaction scale of the SAQ has the smallest difference over time. Mean treatment satisfaction scores are 77.1 +- 10 in coronary heart disease populations. In order to detect a 1-point change in scores over 12months, with repeated measures analyses, at a power of 90% and statistical significance of 5%, 1051 patients would be required. To allow for a 10% patients dropout, recruitment targets will aim for 1,200 patients.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/12/2011
Actual
6/01/2012
Date of last participant enrolment
Anticipated
31/12/2018
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 3018 0
The Queen Elizabeth Hospital - Woodville
Recruitment hospital [2] 3019 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [3] 3020 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment hospital [4] 3021 0
Flinders Medical Centre - Bedford Park

Funding & Sponsors
Funding source category [1] 290007 0
Charities/Societies/Foundations
Name [1] 290007 0
The South Australian Cardiovascular Research Development Program
Country [1] 290007 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] 288691 0
None
Name [1] 288691 0
Address [1] 288691 0
Country [1] 288691 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291713 0
HUMAN RESEARCH ETHICS COMMITTEE (TQEH/LMH/MH)
Ethics committee address [1] 291713 0
Ethics committee country [1] 291713 0
Australia
Date submitted for ethics approval [1] 291713 0
Approval date [1] 291713 0
18/04/2011
Ethics approval number [1] 291713 0
2011012
Ethics committee name [2] 291714 0
Royal Adelaide Hospital Research Ethics Committee
Ethics committee address [2] 291714 0
Ethics committee country [2] 291714 0
Australia
Date submitted for ethics approval [2] 291714 0
Approval date [2] 291714 0
17/08/2011
Ethics approval number [2] 291714 0
110816
Ethics committee name [3] 291715 0
Southern Adelaide Clinical Research Ethics Committee
Ethics committee address [3] 291715 0
Ethics committee country [3] 291715 0
Australia
Date submitted for ethics approval [3] 291715 0
Approval date [3] 291715 0
01/06/2011
Ethics approval number [3] 291715 0
232.11

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

Contacts
Principal investigator
Name 51694 0
Prof John Beltrame
Address 51694 0
The University of Adelaide
Discipline of Medicine
The Queen Elizabeth Hospital
28 Woodville Road
Woodville South
South Australia 5011
Country 51694 0
Australia
Phone 51694 0
+61 8 8222 6740
Fax 51694 0
Email 51694 0
john.beltrame@adelaide.edu.au
Contact person for public queries
Name 51695 0
Rosanna Tavella
Address 51695 0
The University of Adelaide
Discipline of Medicine
The Queen Elizabeth Hospital
28 Woodville Road
Woodville South
South Australia 5011
Country 51695 0
Australia
Phone 51695 0
+61 8 81334016
Fax 51695 0
Email 51695 0
rosanna.tavella@adelaide.edu.au
Contact person for scientific queries
Name 51696 0
Rosanna Tavella
Address 51696 0
The University of Adelaide
Discipline of Medicine
The Queen Elizabeth Hospital
28 Woodville Road
Woodville South
South Australia 5011
Country 51696 0
Australia
Phone 51696 0
+61 8 81334016
Fax 51696 0
Email 51696 0
rosanna.tavella@adelaide.edu.au

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
No additional documents have been identified.