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ANZCTR Newsletter Issue 5, Dec 2009 National and multinational prospective trial registers - The Lancet commentary En route to international clinical trial transparency - The Lancet commentary Declaration of Helsinki now has trial registration requirement (paragraph 19) The 2007 National Health and Medical Research Council (NHMRC) revised National Statement on Ethical Conduct in Human Research includes clause regarding trial registration (page 36, section 3.3.12) The 2007 NHMRC Australian Code for the Responsible Conduct of Research includes a clause regarding trial registration (section 4.10). This Code applies to all NHMRC funded trials The National Ethics Application Form (NEAF) now includes a question regarding details of trial registration (Question 9.1.8.4) ICMJE expands scope of registration ANZCTR is one of the first Primary Registers in the WHO Register Network (Search Portal)
ANZCTR User Survey ANZCTR Statistics International Committee of Medical Journal Editors (ICMJE): June 2007 editorial International Committee of Medical Journal Editors (ICMJE): May 2005 editorial WHO International Clinical Trials Registry Platform (ICTRP) The World Health Organization announces new standards for registration of all human medical research WHO trial registration data set NHMRC Clinical Trials Centre National Health and Medical Research Council (NHMRC) information about the ANZCTR Frequently Asked Questions about the ANZCTR About the ANZCTR How to register a trial How to update a trial

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

Page 4

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

Page 6
Study type: Observational
Purpose: Natural history
Duration: Cross-sectional
Selection: Defined population
Timing: Prospective

Page 7
Phase Not Applicable
Anticipated or actual start date: 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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