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ISRCTN
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ISRCTN09810203
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ClinicalTrials.gov identifier
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Public title
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GEneral Practitioners and Nephrologists for Outpatient Assistance
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Scientific title
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Chronic kidney disease and cardiovascular risk in primary care
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Acronym
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GENOA
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Serial number at source
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N/A
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Study hypothesis
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To analyse the influence of estimated glomerular filtration rate and proteinuria on survival, free of cardiovascular and renal events, and to test the accuracy of calculators including renal function indices in predicting cardiovascular outcomes of primary care patients
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Lay summary
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Ethics approval
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Trial not requiring ethical approval as study design is completely adherent to the recommendations issued by the local ethical committee of Azienda Ospedaliera S. Martino (Genova, Italy) and in accordance to the guidelines issued by the Helsinki declaration.
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Study design
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Retrospective analysis and observational prospective study
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Countries of recruitment
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Italy
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Disease/condition/study domain
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Chronic kidney disease
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Participants - inclusion criteria
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Italian general population followed in primary care
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Participants - exclusion criteria
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Subjects in whom serum creatinine measurement is not available
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Anticipated start date
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01/01/2003
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Anticipated end date
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31/12/2011
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please contact noberasco@ebinobisas.191.it to request a patient information sheet.
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Target number of participants
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70,000
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Interventions
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Data will be extracted from the Health Search Database (HSD). The HSD was set up in 1998 and managed by the Italian College of GPs. The HSD contains information provided by more than 650 Italian GPs, and includes data on more than 1,000,000 individuals.
Demographic, clinical and laboratory data, namely age, sex, body weight, height, blood pressure (BP) values, serum lipids, and serum creatinine will be evaluated for each patient. The presence of diabetes, smoking habits, and the occurrence of previous major cardiovascular events, such as stroke, angina and myocardial infarction will also be extracted from the HSD for each patient. The number and classes of antihypertensive medications will also be retrieved for each patient. Global cardiovascular risk will be calculated for each subject by various calculators including the Framingham, the Heart Score, and the INDANA. Follow-up will be about 5-7 years.
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Primary outcome measure(s)
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Death (any cause)
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Secondary outcome measure(s)
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1. Survival free of cardiovascular events
2. Survival free of renal event
3. Accuracy of different risk calculators in predicting outcome
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Sources of funding
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Carige Foundation (Fondazione Carige [Cassa di Risparmio di Genova e Imperia]) (Italy)
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Trial website
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Publications
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Contact name
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Prof
Giacomo
Deferrari
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Address
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Rettorato Università di Genova
Via Balbi 5
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City/town
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Genova
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Zip/Postcode
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16100
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Country
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Italy
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Sponsor
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Carige Foundation (Fondazione Carige [Cassa di Risparmio di Genova e Imperia]) (Italy)
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Address
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Via G. D'Annunzio 15
16100
Genova
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City/town
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Genova
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Zip/Postcode
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16100
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Country
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Italy
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Date applied
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16/01/2010
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Last edited
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18/02/2010
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Date ISRCTN assigned
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18/02/2010
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