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

NCT01089530 | Completed DMC

• 1 other identifier: P03/07
• Study Type: interventional
• Target: 436
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Risk Factors

Keywords

Fibrinogen; Cholesterol; Cardiovascular risk factors; Primary prevention; High levels fibrinogen; High plasma fibrinogen

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• To assess the effect of this intensive intervention in some modifiable cardiovascular risk factors.

  24 months

Study Arms (1)

Standard care

NO INTERVENTION

Behavioral: Lifestyle intensive group

Interventions

Lifestyle intensive group BEHAVIORAL

hipocaloric diet smoking cessation physical exercise

Standard care

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients receiving lipid lowering treatment (including dietary measures)
• Local or generalized, acute or chronic infection.
• Patients with a history of cardiovascular disease.

Sponsors & Collaborators

• Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina: lead
• SCMFIC FAMILY DOCTORS CATALAN SOCIETY GRANT: collaborator

Study Sites (1)

ABS Florida Sud

L'Hospitalet Del Llobregat, Barcelona, 08905, Spain

Location

Related Publications (1)

• Rodriguez Cristobal JJ, Alonso-Villaverde Grote C, Trave Mercade P, Perez Santos JM, Pena Sendra E, Munoz Lloret A, Fernandez Perez C, Bleda Fernandez D; EFAP group. Randomised clinical trial of an intensive intervention in the primary care setting of patients with high plasma fibrinogen in the primary prevention of cardiovascular disease. BMC Res Notes. 2012 Mar 1;5:126. doi: 10.1186/1756-0500-5-126.

  PMID: 22381072 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 10, 2010
• First Posted: March 18, 2010
• Study Start: January 1, 2003
• Study Completion: December 1, 2006
• Last Updated: March 18, 2010

Record last verified: 2010-03

Locations

ES (1)