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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

436 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2006-12-31

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.

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Detailed Description

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Conditions

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Cardiovascular Risk Factors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Standard care

Group Type NO_INTERVENTION

Lifestyle intensive group

Intervention Type BEHAVIORAL

hipocaloric diet smoking cessation physical exercise

Interventions

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Lifestyle intensive group

hipocaloric diet smoking cessation physical exercise

Intervention Type BEHAVIORAL

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.

Minimum Eligible Age

35 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No