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

Not Applicable

Completed

• Conditions: Cardiovascular Risk Factors
• Interventions: Behavioral: Lifestyle intensive group

• Registration Number: NCT01089530
• Lead Sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-01
• Study Completion: 2006-12
• Study First Submitted: 2010-02-10
• Status Verified: 2010-03
• Study First Submitted QC: 2010-03-17
• Last Update Submitted: 2010-03-17
• Study First Posted: 2010-03-18
• Last Update Posted: 2010-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 436

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard care	Lifestyle intensive group	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
To assess the effect of this intensive intervention in some modifiable cardiovascular risk factors.	24 months

Trial Locations

Locations (1)

ABS Florida Sud; 🇪🇸 L'Hospitalet del Llobregat, Barcelona, Spain