Clinical trial NCT01089530: Clinical Intervention Study in the Primary Care Setting of Patients With High Plasma Fibrinogen (EFAP)
Official title: Clinical Intervention Study in the Primary Care Setting of Patients With High Plasma Fibrinogen in Primary Prevention of Cardiovascular Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Risk Factors
Keywords: Fibrinogen
Cholesterol
Cardiovascular risk factors
Primary prevention
High levels fibrinogen
High plasma fibrinogen
Lead sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Sponsor class: OTHER
Collaborators: name: SCMFIC FAMILY DOCTORS CATALAN SOCIETY GRANT
First posted: 2010-03-18
Enrollment: 436
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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.

Primary outcomes:
measure: To evaluate the effect of an intensive intervention to modify lifestyle (hypocaloric diet, smoking cessation and physical exercise) in the fibrinogen levels.
timeFrame: 24 months
Secondary outcomes:
measure: To assess the effect of this intensive intervention in some modifiable cardiovascular risk factors.
timeFrame: 24 months
Other outcomes:
Locations:
city: L'Hospitalet del Llobregat
country: Spain
facility: ABS Florida Sud
state: Barcelona
Study officials:
References:
citation: 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.