Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000883213
Ethics application status
Approved
Date submitted
6/10/2009
Date registered
9/10/2009
Date last updated
12/01/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Prospective observational longitudinal registry of patients with stable coronary artery disease
Scientific title
Prospective observational longitudinal registry of patients with stable coronary artery disease
Secondary ID [1] 283789 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
CLARIFY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Artery Disease 251964 0
Condition category
Condition code
Cardiovascular 252150 252150 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
Observation of standard management of coronary artery disease patients over a 5 year period. Observations will be recorded at baseline and then every 12 months for 5 years. Data will be recorded detailing; patient demographics, cardiovascular risk factors, medical history, physical status (height, weight, electrocardiogram, blood test results for lipids and glucose) and current medications.
Intervention code [1] 241378 0
Not applicable
Comparator / control treatment
No treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 253022 0
To characterise contemporary coronary artery disease (CAD) patients in terms of; demographic characteristics, clinical profiles and management and outcomes to identify gaps between treatment and evidence
Timepoint [1] 253022 0
5 years after recruitment
Secondary outcome [1] 257835 0
To determine the long term prognostic determinants in this population, including resting heart rate (measured using an electrcardiogram), with a view to developing a risk prediction model. A statistic regression model will be used to determine the factors with prognostic importance.
Timepoint [1] 257835 0
5 years after recruitment

Eligibility
Key inclusion criteria
Outpatients with stable coronary artery disease proven by history of at least one of the following criteria:
- documented myocardial infarction (>3months ago)
- coronary angiography showing at least one coronary stenosis of more than 50%
- chest pain with myocardial ischaemia proven by stress electrocardiogram, stress echocardiography or myocardial imaging
- coronary artery bypass graft or percutaneous coronary intervention (>3 months ago)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients hospitalised for cardiovascular disease within last 3 months (including revascularisation)
- Patients with planned revascularisation
- Conditions hampering participation in the 5 year follow up, such as limited cooperation, limited legal capacity, serious non-cardiovascular disease or conditions interfering with life expectancy (cancer, drug abuse etc) or severe cardiovascular disease (advanced heart failure, severe valve disease, history of valve repair/replacement etc)

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/12/2009
Actual
18/02/2010
Date of last participant enrolment
Anticipated
Actual
28/06/2010
Date of last data collection
Anticipated
Actual
30/09/2015
Sample size
Target
30000
Accrual to date
Final
32703
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA,VIC
Recruitment outside Australia
Country [1] 2222 0
France
State/province [1] 2222 0
Country [2] 2223 0
Austria
State/province [2] 2223 0
Country [3] 2224 0
Belgium
State/province [3] 2224 0
Country [4] 2225 0
Denmark
State/province [4] 2225 0
Country [5] 2226 0
Finland
State/province [5] 2226 0
Country [6] 2227 0
Germany
State/province [6] 2227 0
Country [7] 2228 0
Greece
State/province [7] 2228 0
Country [8] 2229 0
Ireland
State/province [8] 2229 0
Country [9] 2230 0
Italy
State/province [9] 2230 0
Country [10] 2231 0
Netherlands
State/province [10] 2231 0
Country [11] 2232 0
Portugal
State/province [11] 2232 0
Country [12] 2233 0
Spain
State/province [12] 2233 0
Country [13] 2234 0
Switzerland
State/province [13] 2234 0
Country [14] 2235 0
United Kingdom
State/province [14] 2235 0
Country [15] 2236 0
Bulgaria
State/province [15] 2236 0
Country [16] 2237 0
Czech Republic
State/province [16] 2237 0
Country [17] 2238 0
Hungary
State/province [17] 2238 0
Country [18] 2239 0
Latvia
State/province [18] 2239 0
Country [19] 2240 0
Poland
State/province [19] 2240 0
Country [20] 2241 0
Romania
State/province [20] 2241 0
Country [21] 2242 0
Russian Federation
State/province [21] 2242 0
Country [22] 2243 0
Slovakia
State/province [22] 2243 0
Country [23] 2244 0
Slovenia
State/province [23] 2244 0
Country [24] 2245 0
Ukraine
State/province [24] 2245 0
Country [25] 2246 0
United States of America
State/province [25] 2246 0
Country [26] 2247 0
Canada
State/province [26] 2247 0
Country [27] 2248 0
Argentina
State/province [27] 2248 0
Country [28] 2249 0
Brazil
State/province [28] 2249 0
Country [29] 2250 0
Mexico
State/province [29] 2250 0
Country [30] 2251 0
Saudi Arabia
State/province [30] 2251 0
Country [31] 2252 0
South Africa
State/province [31] 2252 0
Country [32] 2253 0
China
State/province [32] 2253 0
Country [33] 2254 0
Korea, Democratic People's Republic Of
State/province [33] 2254 0
Country [34] 2255 0
Malaysia
State/province [34] 2255 0
Country [35] 2256 0
Singapore
State/province [35] 2256 0
Country [36] 2257 0
Thailand
State/province [36] 2257 0

Funding & Sponsors
Funding source category [1] 243839 0
Commercial sector/Industry
Name [1] 243839 0
Servier Laboratories Australia Pty Ltd
Country [1] 243839 0
Australia
Primary sponsor type
Individual
Name
Philippe Gabriel Steg
Address
Depatement de Cardiologie
Centre Hospitalier Bichat-Claude Bernard
46 rue Henri-Huchard
75018 Paris
Country
France
Secondary sponsor category [1] 237185 0
Individual
Name [1] 237185 0
Kim Fox
Address [1] 237185 0
Imperial College London,
South Kensington Campus,
London SW7 2AZ
Country [1] 237185 0
United Kingdom
Secondary sponsor category [2] 237186 0
Individual
Name [2] 237186 0
Roberto Ferrari
Address [2] 237186 0
Sant'Anna University Hospital of Ferrara, C.so Giovecca 203, 44100,
Ferrara
Country [2] 237186 0
Italy
Secondary sponsor category [3] 237187 0
Individual
Name [3] 237187 0
Ian Ford
Address [3] 237187 0
e-Science Hub
Kelvin Building
Glasgow G12 8QQ
Country [3] 237187 0
United Kingdom
Secondary sponsor category [4] 237188 0
Individual
Name [4] 237188 0
Michael Tendera
Address [4] 237188 0
Cardiology Division,
Medical University of Silesia,
Katowice
Country [4] 237188 0
Poland
Secondary sponsor category [5] 237189 0
Individual
Name [5] 237189 0
Jean Claude Tardif
Address [5] 237189 0
Montreal Heart Institute
5000, Belanger Street
Montreal, Quebec H1T 1C8
Country [5] 237189 0
Canada
Other collaborator category [1] 888 0
Individual
Name [1] 888 0
Assoc/Prof Chris Reid
Address [1] 888 0
Faculty of Medicine Nursing and Health Sciences
3rd Floor, Burnet Building, AMREP
89 Commercial Rd
Melbourne Vic 3004
Country [1] 888 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243964 0
Bellberry Ltd
Ethics committee address [1] 243964 0
Ethics committee country [1] 243964 0
Australia
Date submitted for ethics approval [1] 243964 0
28/10/2009
Approval date [1] 243964 0
30/11/2009
Ethics approval number [1] 243964 0

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

Contacts
Principal investigator
Name 30358 0
A/Prof Chris Reid
Address 30358 0
The Alfred Centre
6th Floor, 99 Commercial Road
Melbourne VIC 3004
Australia
Country 30358 0
Australia
Phone 30358 0
+ 61 3 9903 0050
Fax 30358 0
Email 30358 0
[email protected]
Contact person for public queries
Name 13605 0
Louise Shiel
Address 13605 0
Monash University
Caulfield Hospital
Grd Floor, Fethers Block
260 Kooyong Rd
Caulfield VIC 3162
Country 13605 0
Australia
Phone 13605 0
+61 3 9076 6169
Fax 13605 0
Email 13605 0
[email protected]
Contact person for scientific queries
Name 4533 0
Louise Shiel
Address 4533 0
Monash University
Caulfield Hospital
Grd Floor, Fethers Block
260 Kooyong Rd
Caulfield VIC 3162
Country 4533 0
Australia
Phone 4533 0
+61 3 9076 6169
Fax 4533 0
Email 4533 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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