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Australian New Zealand Clinical Trials Registry

Trial Details
indicate updates made to monitored data item(s) since trial registration. These data item(s) are monitored to ensure they comply with the WHO / journal editors standards.
 
Request Number: 082945
ACTR Number: ACTRN12608000347369
Trial Status: Registered
Date Submitted: 7/07/2008
Date Registered: 22/07/2008

Page 1

Public title: The Coronary Artery Disease in General Practice Study
ANZCTR registration title: The prevalence of persistent angina in a primary care setting assessed by a cross-sectional survey
Secondary ID:Nil 
UTN:
Trial acronym: CADENCE

Page 2

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

Page 3

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: 
Comparator / control treatment: Not applicable - observational study
Control group: Uncontrolled

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Primary outcome: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:March 2007 
Secondary outcome:Examine predictors of persistent regular angina episodes using the survey data provided and a logistic regression model. 
Timepoint:March 2007 

Page 5

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
Gender: Both males and females
Healthy volunteers? No
Key exclusion criteria: Inability to read or give informed consent in English Inability to complete a written questionnaire in English

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Study type: Observational
Purpose: Natural history
Duration: Cross-sectional
Selection: Defined population
Timing: Prospective

Page 7

Phase Not Applicable
Anticipated or actual date of first participant enrolement: 15/09/2006
Target sample size: 3003
Recruitment status: Completed

Page 8

Funding source:Commercial sector/Industry 
Name:Servier Laboratories 
Address:8 Cato Street Hawthorn VIC 3122 
Country:Australia 
Primary sponsor: 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:None 
Name: 
Address: 
Country: 
Other collaborator:Commercial sector/Industry 
Name:Servier Laboratories 
Address:8 Cato Street Hawthorn VIC 3122 
Country:Australia 

Page 9

Has the study received approval from at least one ethics committee? Yes
Ethics Committee name:Royal Australian College of General Practitioners National Research and Evaluation Ethics Committee 
Address:1 Palmerston Crescent South Melbourne VIC 3205 
Country:Australia 
Date of approval:13/06/2006 
HREC Number:NREEC 06/12 
Countries of recruitment:Australia 
Brief summary: This study will assess how a sample group of approximately 3000 angina patients are being managed in Australia.
Trial website:
Presentations / publication list: The prevalence of weekly angina among patients with chronic stable angina in primary care practices, Arch Intern Med. 2009;169(16):1491-1499

Page 10

Contact person for public queries
Name: Dr Andrew Weekes
Address: 8 Cato Street
Hawthorn VIC 3122
Country: Australia
Tel: 1800 654 311
Fax: 03 9822 4190
Email: andrew.weekes@au.netgrs.com

Contact person for scientific queries
Name: Dr Andrew Weekes
Address: 8 Cato Street
Hawthorn VIC 3122
Country: Australia
Tel: 1800 654 311
Fax: 03 9822 4190
Email: andrew.weekes@au.netgrs.com

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