NCT01089530

Clinical Intervention Study in the Primary Care Setting of Patients With High Plasma Fibrinogen (EFAP)

Clinical Intervention Study in the Primary Care Setting of Patients With High Plasma Fibrinogen in Primary Prevention of Cardiovascular Disease

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 436 (planned)
• Sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina · Academic / Other
• Sex: All
• Age: 35 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Objectives: * To study the possible effects of an intensive lifestyle change program on, the plasma fibrinogen levels in patients with no cardiovascular disease, with a high fibrinogen and normal cholesterol levels, and moderate Cardiovascular Risk (CVR). * To analyse whether or not the effect on fibrinogen is independent of the effect on lipids. Methods: Controlled, randomised clinical trial in 13 Basic Health Areas (BHA) in L'Hospitalet de Llobregat (Barcelona) and Barcelona city. Of the 436 patients between 35 and 75 years with no cardiovascular disease, with a high plasma fibrinogen (\> 300 mg/dl) and a plasma cholesterol \< 250 mg/dl, 218 received a more frequent and intensive intervention, consisting of advice on lifestyle changes and treatment. The follow up frequency of the intervention group was every two months. The other 218 patients continued with their usual care in the BHAs. Fibrinogen, plasma cholesterol and other clinical biochemistry parameters were assessed.

Conditions

• Cardiovascular Risk Factors

Interventions

Type	Name	Description
BEHAVIORAL	Lifestyle intensive group	hipocaloric diet smoking cessation physical exercise

Timeline

• Start date: 2003-01-01
• Completion: 2006-12-01
• First posted: 2010-03-18
• Last updated: 2010-03-18

Locations

1 site across 1 country: Spain