title: 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.
abstract: BACKGROUND
  We have studied the possible effects of an intensive lifestyle change program on plasma fibrinogen levels, in patients with no cardiovascular disease, with elevated levels of fibrinogen, normal cholesterol levels, and a moderate estimated risk of coronary heart disease (CHD) and we have also analysed whether the effect on fibrinogen is independent of the effect on lipids.
  
  
  RESULTS
  This clinical trial was controlled, unblinded and randomized, with parallel groups, done in 13 Basic Health Areas (BHA) in l'Hospitalet de Llobregat (Barcelona) and Barcelona city. The study included 436 patients, aged between 35 and 75 years, with no cardiovascular disease, elevated levels of fibrinogen (> 300 mg/dl), cholesterol < 250 mg/dl, 218 of whom received a more intensive intervention consisting of advice on lifestyle and treatment. The follow-up frequency of the intervention group was every 2 months. The other 218 patients followed their standard care in the BHAs. Fibrinogen, plasma cholesterol and other clinical biochemistry parameters were assessed.The evaluation of the baseline characteristics of the patients showed that both groups were homogenous. Obesity and hypertension were the most prevalent risk factors. After 24 months of the study, statistically significant changes were seen between the adjusted means of the two groups, for the following parameters: fibrinogen, plasma cholesterol, systolic and diastolic blood pressure and body mass index.
  
  
  CONCLUSIONS
  Intensive intervention to achieve lifestyle changes has shown to be effective in reducing some of the estimated CHD factors. However, the effect of intensive intervention on plasma fibrinogen levels did not correlate with the variations in cholesterol.
  
  
  BACKGROUND
  ClinicalTrials.gov: NCT01089530.
authors.affiliation: Medicina, Area Básica Salud Florida Sud, Parc dels Ocellets, L'Hospitalet del Llobregat, Barcelona, Spain. 21002jrc@comb.es
authors.forename: Juan José
authors.initials: JJ
authors.lastname: Rodríguez Cristóbal
authors.forename: Carlos
authors.initials: C
authors.lastname: Alonso-Villaverde Grote
authors.forename: Pere
authors.initials: P
authors.lastname: Travé Mercadé
authors.forename: José Ma
authors.initials: JM
authors.lastname: Pérez Santos
authors.forename: Esther
authors.initials: E
authors.lastname: Peña Sendra
authors.forename: Anna
authors.initials: A
authors.lastname: Muñoz Lloret
authors.forename: Cristina
authors.initials: C
authors.lastname: Fernández Pérez
authors.forename: Domingo
authors.initials: D
authors.lastname: Bleda Fernández
mesh_terms: D000328:Adult; D000368:Aged; D001794:Blood Pressure; D015992:Body Mass Index; D002318:Cardiovascular Diseases / Q000517:prevention & control*; D002784:Cholesterol / Q000097:blood*; D004032:Diet; D015444:Exercise; D005260:Female; D005340:Fibrinogen / Q000032:analysis*; D006801:Humans; D006973:Hypertension / Q000503:physiopathology; D008019:Life Style; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000503:physiopathology; D011320:Primary Health Care; D011322:Primary Prevention; D012307:Risk Factors; D012907:Smoking; D016540:Smoking Cessation
chemical_list: D005340:Fibrinogen; D002784:Cholesterol