Registry to provide contemporary information regarding characteristics, management and outcomes of outpatients with stable coronary artery disease
ISRCTN | ISRCTN43070564 |
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DOI | https://doi.org/10.1186/ISRCTN43070564 |
Secondary identifying numbers | N/A |
- Submission date
- 13/05/2011
- Registration date
- 13/06/2011
- Last edited
- 09/01/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration and not expected to be available in the future
Contact information
Prof Philippe Gabriel Steg
Scientific
Scientific
Centre Hospitalier Bichat-Claude Bernard
46 Rue Henri Huchard
Paris
75018
France
Study information
Study design | Multicentre prospective observational longitudinal study |
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Primary study design | Observational |
Secondary study design | Longitudinal study |
Study setting(s) | Hospital |
Study type | Screening |
Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
Scientific title | ProspeCtive observational LongitudinAl RegIstry oF patients with stable coronary arterY disease |
Study acronym | CLARIFY |
Study objectives | Most of the data pertaining to patients with stable coronary artery disease come from randomised clinical trials involving highly selective patient population. This large international observational registry will attempt to provide contemporary information regarding characteristics, management and outcomes of outpatients with stable coronary artery disease. |
Ethics approval(s) | National Research Ethics Service, Isle of Wight, Portsmouth and Southeast Hampshire Research Ethics Committee, UK approved on 20/11/2009. All other centres obtained ethics approval before recruitment of the first participant. |
Health condition(s) or problem(s) studied | Coronary artery disease |
Intervention | The registry attempted to collect representative data for each of the participating countries. Representativeness is ensured by a two-tiered process: 1. Determination of physician type in charge of outpatients with stable CAD in a given country and targeting of an appropriate proportion of each of this physician's specialties 2. For each physician, enrollment of consecutive, eligible patients. The data will be collected prospectively using an electronic standardised international case report form (translated into the local language) at baseline and annually during 5 years follow up (at 12+/-3, 24+/-3, 36+/-3, 48+/-3, and 60+/-3 months). |
Intervention type | Other |
Primary outcome measure | Information collected at baseline will include demographics, medical history, risk factors, employment status, physical examination, heart rate, laboratory values (if available), and current chronic medical treatments. Each annual follow-up visit will collect information regarding clinical events, hospitalisations, interventions, death, employment status, physical examination, heart rate, laboratory values (if available) and current medical therapy (cardiovascular and non-cardiovascular). |
Secondary outcome measures | No secondary outcome measures |
Overall study start date | 01/11/2009 |
Completion date | 30/07/2015 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 33,000 |
Total final enrolment | 32954 |
Key inclusion criteria | Outpatients with stable coronary artery disease, proven by history of at least one of the following criteria: 1. Documented myocardial infarction (more than 3 months ago) 2. Coronary stenosis of more than 50% proven by coronary angiography 3. Chest pain with proven myocardial ischemia 4. Coronary artery bypass grafting surgery or percutaneous coronary intervention (more than 3 months ago) |
Key exclusion criteria | 1. Patients hospitalised for cardiovascular disease within last 3 months 2. Patients with planned revascularisation 3. Conditions hampering the participation or the 5-year follow-up |
Date of first enrolment | 01/11/2009 |
Date of final enrolment | 30/07/2015 |
Locations
Countries of recruitment
- Argentina
- Australia
- Austria
- Bahrain
- Barbados
- Belgium
- Brazil
- Bulgaria
- Canada
- China
- Czech Republic
- Denmark
- France
- Germany
- Greece
- Hungary
- Ireland
- Italy
- Korea, South
- Kuwait
- Latvia
- Lithuania
- Malaysia
- Mexico
- Netherlands
- Oman
- Poland
- Portugal
- Qatar
- Romania
- Russian Federation
- Saudi Arabia
- Singapore
- Slovakia
- Slovenia
- South Africa
- Spain
- Switzerland
- Thailand
- Ukraine
- United Arab Emirates
- United Kingdom
- Viet Nam
Study participating centre
Centre Hospitalier Bichat-Claude Bernard
Paris
75018
France
75018
France
Sponsor information
Institut de Recherches Internationales Servier (France)
Industry
Industry
50 rue Carnot
Suresnes
92284
France
Website | http://www.servier.com/ |
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https://ror.org/034e7c066 |
Funders
Funder type
Industry
Institut de Recherches Internationales Servier (France)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan | Not provided at time of registration |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Results article | results | 22/07/2014 | Yes | No | |
Results article | results | 01/10/2014 | Yes | No | |
Results article | results | 27/04/2015 | Yes | No | |
Results article | results | 01/08/2015 | Yes | No | |
Results article | results | 01/01/2016 | Yes | No | |
Results article | results | 01/07/2019 | 03/06/2020 | Yes | No |
Results article | 5-year results | 15/07/2021 | 16/07/2021 | Yes | No |
Results article | 07/01/2023 | 09/01/2023 | Yes | No |
Editorial Notes
09/01/2023: Publication reference added.
16/07/2021: Publication reference added.
02/06/2020: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the 2015 reference.
12/04/2016: Publication reference added.
28/01/2016: Publication reference added.