Download 2,89 Mo - CLARIFY registry

The management of outpatients with stable
coronary artery disease in clinical practice
Need for contemporary data in
stable CAD
 Data from randomized clinical trials often have limited
external validity (generalizability)
 highly selected patient populations
 often limited to specific geographic settings
 often limited to pts with angina or with acute coronary
syndrome
 most data pertain to hospitalized patients
 many studies antedate the advent of modern
prescriptions
 In addition, there is a lack data on heart rate actually
achieved in practice and its relation to outcomes
CAD: coronary artery disease
Worldwide contemporary registry in
outpatients with stable CAD
 An international, prospective, observational
longitudinal registry in outpatients with stable CAD
 The population of the CLARIFY will cover the entire
spectrum of the outpatients with CAD
 5 years follow-up
CAD: coronary artery disease
39 countries
Latvia
Austria
France
Belgium/lLuxembourg
Germany
Lithuania
Bulgaria
Greece
Netherlands
Czech Republic
Denmark
Europe
Poland
Slovakia
Portugal
Slovenia
Hungary
Romania
Ukraine
Italy
Russia
Lithuania
Ireland
Spain
Finland
UK
Americas
Argentina
Brazil
Canada
Mexico
Asia
West Indies
China
Middle East & Africa
Korea
Gulf Countries
Malaysia
Saudi Arabia
Singapore
South Africa
Thailand
Australia
Objectives
 Characterize contemporary CAD patients (demographic
characteristics, clinical profile)
 Describe their management and outcomes over 5 years
of follow-up
 Identify gaps between treatment and evidence
 Determine the long-term prognostic determinants in CAD,
including resting heart rate, and develop a robust risk
prediction model
CAD: coronary artery disease
Inclusion criteria
Stable coronary artery disease proven by history of
at least one of the following:
 Documented myocardial infarction (more than 3 months ago)
 Coronary angiography showing at least one coronary stenosis
of more than 50%
 Chest pain with myocardial ischemia proven by stress ECG,
stress echocardiography or myocardial imaging
 PCI or CABG (more than 3 months ago)
Data collection
Follow-up
Baseline
12 months
24 months
36 months
48 months
60 months
Data
to be
collected
(eCRF)
History and
clinical
examination;
regular
medications
Clinical examination;
regular medications;
clinical outcomes
* Every 6 months – phone call (health status, address)
Importance of CLARIFY
 Will provide data on HR and outcomes in “real world”
contemporary outpatients with stable CAD; clinical and
demographic aspects of the disease and treatment
 Will provide dynamic estimation of the changing patterns of HR
management, disease presentation, and therapy
 Will help to develop a risk prediction tool based on HR
 Will give robust data for global and national publications, for
scientific communications (congresses, abstracts), for health
care administrators
 Will provide data for educational programs
HR: heart rate
CAD: coronary artery disease