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

Cardiovascular Risk Factors Clinical Trial

— EFAP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01089530
• Other study ID #: P03/07
• Status: Completed
• Phase: N/A
• First received: February 10, 2010
• Last updated: March 17, 2010
• Start date: January 2003
• Est. completion date: December 2006

Study information

• Verified date: March 2010
• Source: Jordi Gol i Gurina Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 436
• Est. completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 75 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Cardiovascular Risk Factors

Intervention

Behavioral:
• Lifestyle intensive group
hipocaloric diet smoking cessation physical exercise

Locations

Country	Name	City	State
Spain	ABS Florida Sud	L'Hospitalet del Llobregat	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Jordi Gol i Gurina Foundation	SCMFIC FAMILY DOCTORS CATALAN SOCIETY GRANT

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the effect of an intensive intervention to modify lifestyle (hypocaloric diet, smoking cessation and physical exercise) in the fibrinogen levels.		24 months	No
Secondary	To assess the effect of this intensive intervention in some modifiable cardiovascular risk factors.		24 months	No