Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000347369
Ethics application status
Approved
Date submitted
7/07/2008
Date registered
22/07/2008
Date last updated
26/10/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Coronary Artery Disease in General Practice Study
Scientific title
The prevalence of persistent angina in a primary care setting assessed by a cross-sectional survey
Secondary ID [1] 624 0
Nil
Universal Trial Number (UTN)
Trial acronym
CADENCE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Stable Angina 3343 0
Condition category
Condition code
Cardiovascular 3496 3496 0 0
Coronary heart disease

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Cross-sectional survey to identify the prevalence of persistent angina in the Australian primary care setting. General Practitioner's completed a case report form for consecutive patients with a clinical diagnosis of chronic stable angina. The case report form included patient demographics, medical history, medications etc. and took approximately 10 minutes to complete. Each patient completed a modified version of the Seattle Angina Questionnaire, a validated symptom/quality of life instrument. This took approximately 5 minutes to complete. The data was collected prospectively over a period of 6 months.
Intervention code [1] 3076 0
Not applicable
Comparator / control treatment
Not applicable - observational study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 4401 0
The prevalance of persistent angina in a primary care setting will be determined using the answers to questions 1 and 2 of the Seattle Angina Questionnaire.
Timepoint [1] 4401 0
March 2007
Secondary outcome [1] 7431 0
Examine predictors of persistent regular angina episodes using the survey data provided and a logistic regression model.
Timepoint [1] 7431 0
March 2007

Eligibility
Key inclusion criteria
Adults >= 18 years old who have ever had a clinical diagnosis of angina pectoris
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to read or give informed consent in English
Inability to complete a written questionnaire in English

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/09/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
3003
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3539 0
Commercial sector/Industry
Name [1] 3539 0
Servier Laboratories
Country [1] 3539 0
Australia
Primary sponsor type
Individual
Name
A/Prof John Beltrame
Address
The Queen Elizabeth Hospital, Cardiology Unit
University of Adelaide
28 Woodville Rd
Woodville South
SA 5011
Country
Australia
Secondary sponsor category [1] 3178 0
None
Name [1] 3178 0
Address [1] 3178 0
Country [1] 3178 0
Other collaborator category [1] 322 0
Commercial sector/Industry
Name [1] 322 0
Servier Laboratories
Address [1] 322 0
8 Cato Street
Hawthorn VIC 3122
Country [1] 322 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5596 0
Royal Australian College of General Practitioners National Research and Evaluation Ethics Committee
Ethics committee address [1] 5596 0
1 Palmerston Crescent
South Melbourne VIC 3205
Ethics committee country [1] 5596 0
Australia
Date submitted for ethics approval [1] 5596 0
12/05/2006
Approval date [1] 5596 0
13/06/2006
Ethics approval number [1] 5596 0
NREEC 06/12

Summary
Brief summary
This study will assess how a sample group of approximately 3000 angina patients are being managed in Australia.
Trial website
Trial related presentations / publications
The prevalence of weekly angina among patients with chronic stable angina in primary care practices, Arch Intern Med. 2009;169(16):1491-1499
Public notes

Contacts
Principal investigator
Name 28714 0
Address 28714 0
Country 28714 0
Phone 28714 0
Fax 28714 0
Email 28714 0
Contact person for public queries
Name 11871 0
Dr Andrew Weekes
Address 11871 0
8 Cato Street
Hawthorn VIC 3122
Country 11871 0
Australia
Phone 11871 0
1800 654 311
Fax 11871 0
03 9822 4190
Email 11871 0
[email protected]
Contact person for scientific queries
Name 2799 0
Dr Andrew Weekes
Address 2799 0
8 Cato Street
Hawthorn VIC 3122
Country 2799 0
Australia
Phone 2799 0
1800 654 311
Fax 2799 0
03 9822 4190
Email 2799 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
No additional documents have been identified.