GEneral Practitioners and Nephrologists for Outpatient Assistance
| ISRCTN | ISRCTN09810203 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN09810203 |
| Protocol serial number | N/A |
| Sponsor | Carige Foundation (Fondazione Carige [Cassa di Risparmio di Genova e Imperia]) (Italy) |
| Funder | Carige Foundation (Fondazione Carige [Cassa di Risparmio di Genova e Imperia]) (Italy) |
- Submission date
- 16/01/2010
- Registration date
- 18/02/2010
- Last edited
- 18/02/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Giacomo Deferrari
Scientific
Scientific
Rettorato Università di Genova
Via Balbi 5
Genova
16100
Italy
Study information
| Primary study design | Observational |
|---|---|
| Study design | Retrospective analysis and observational prospective study |
| Secondary study design | Other |
| Study type | Participant information sheet |
| Scientific title | Chronic kidney disease and cardiovascular risk in primary care |
| Study acronym | GENOA |
| Study objectives | 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 |
| Ethics approval(s) | 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. |
| Health condition(s) or problem(s) studied | Chronic kidney disease |
| Intervention | 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. |
| Intervention type | Other |
| Primary outcome measure(s) |
Death (any cause) |
| Key secondary outcome measure(s) |
1. Survival free of cardiovascular events |
| Completion date | 31/12/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 70000 |
| Key inclusion criteria | Italian general population followed in primary care |
| Key exclusion criteria | Subjects in whom serum creatinine measurement is not available |
| Date of first enrolment | 01/01/2003 |
| Date of final enrolment | 31/12/2011 |
Locations
Countries of recruitment
- Italy
Study participating centre
Rettorato Università di Genova
Genova
16100
Italy
16100
Italy
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
