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

NCT01089530 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 436

Last updated 2010-03-18

No results posted yet for this study

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.

Conditions

  • Cardiovascular Risk Factors

Interventions

BEHAVIORAL

Lifestyle intensive group

hipocaloric diet smoking cessation physical exercise

Sponsors & Collaborators

  • SCMFIC FAMILY DOCTORS CATALAN SOCIETY GRANT

    collaborator UNKNOWN

  • Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-01-31
Completion
2006-12-31

Countries

  • Spain

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01089530 on ClinicalTrials.gov