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 Research Notes

Domingo Bleda Fernández⁶  Cristina Fernández Pérez¹  Anna Muñoz Lloret²  Esther Peña Sendra⁵  José Mª Pérez Santos³  Pere Travé Mercadé⁴  Carlos Alonso-Villaverde Grote⁵  Juan José Rodríguez Cristóbal³ 

[1] Unidad de Apoyo a la Investigación, Hospital Clínico San Carlos, Madrid, Spain;Departamento médico, Abbott Healthcare, Barcelona, Spain;Medicina, Area Básica Salud Florida Sud, Parc dels Ocellets, L'Hospitalet del Llobregat, Barcelona, Spain;Laboratorio Analisis Clínicos. Centro Asistencia Primaria Just Oliveras, L'Hospitalet del Llobregat, Barcelona, Spain;Institut Català de Ciències Cardiovasculars, Centre Superior d'Investigacions Científiques, Barcelona, Spain;Hospital de Viladecans, Viladecans, Barcelona, Spain

关键词: Primary prevention;    Cardiovascular risk factors;    Cholesterol;    Fibrinogen;   

Others  :  1166616
DOI  :  10.1186/1756-0500-5-126

 received in 2011-07-05, accepted in 2012-03-01,  发布年份 2012

【 摘 要 】

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.

Conclusion

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.

Trial Registration

ClinicalTrials.gov: NCT01089530

【 授权许可】

   
2012 Rodríguez Cristóbal et al; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

Figure 2.

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