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

Study Overview
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Brief Summary
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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.

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

Conditions
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Cardiovascular Risk Factors

Intervention / Treatment
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* Behavioral: Lifestyle intensive group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged between 30 and 75 years, than in 2 analytical consecutive, separated by a minimum interval of 15 days, have fibrinogen plasma > 300 mg/dl and plasma Total cholesterol < 250 mg/dl. Acceptance through informed consent of the patient to participate in the study. Exclusion Criteria: Patients receiving lipid lowering treatment (including dietary measures) Local or generalized, acute or chronic infection. Patients with a history of cardiovascular disease.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard care<br> | Behavioral: Lifestyle intensive group<br>* hipocaloric diet smoking cessation physical exercise<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the effect of an intensive intervention to modify lifestyle (hypocaloric diet, smoking cessation and physical exercise) in the fibrinogen levels. |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the effect of this intensive intervention in some modifiable cardiovascular risk factors. |  | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fibrinogen, Cholesterol, Cardiovascular risk factors, Primary prevention, High levels fibrinogen, High plasma fibrinogen