Clinical Intervention Study in the Primary Care Setting of Patients With High Plasma Fibrinogen (EFAP)
- 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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
|Official Title:||Clinical Intervention Study in the Primary Care Setting of Patients With High Plasma Fibrinogen in Primary Prevention of Cardiovascular Disease|
- To evaluate the effect of an intensive intervention to modify lifestyle (hypocaloric diet, smoking cessation and physical exercise) in the fibrinogen levels. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- To assess the effect of this intensive intervention in some modifiable cardiovascular risk factors. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
|Study Start Date:||January 2003|
|Estimated Study Completion Date:||December 2006|
|No Intervention: Standard care||
Behavioral: Lifestyle intensive group
hipocaloric diet smoking cessation physical exercise