The purpose of this study was to evaluate whether an intensified multifactorial intervention program about cardiovascular risk factors in subjects with peripheral arterial disease (with and without diabetes mellitus), can improve the control of these factors (mainly hypercholesterolemia and hypertension) in relation to the habitual care

Condition	Intervention	Phase
Peripheral Arterial Disease Hypercholesterolemia Hypertension Diabetes Mellitus Smoking	Drug: Stepwise therapy for dyslipidemia, hypertension and diabetes  Behavior: Dietary recommendations  Behavior: Increase in physical activity  Behavior: Smoking cessation	Phase IV

Further Study Details: 

Primary Outcomes: Lowering of LDL cholesterol concentrations and blood pressure levels (at 12 months). Increase in use of antiplatelet agents (at 12 months)
Secondary Outcomes: Decrease in basal glycaemia and HbA1c(only subjects with diabetes); Lowering of serum triglycerides and total cholesterol.; Increase in serum HDL cholesterol; Improvement in cardiovascular risk (Framingham Score and UKPDS engine); Weight reduction; Increase in physical activity; Changes in dietary intake; Smoking cessation; Improvement in health-related quality of life (SF-36); Improvement of intermittent claudication; Improvement of arm-ankle index; Effect of control of cardiovascular risk factors on metabolic and inflammatory markers associated with cardiovascular disease; Changes in serum concentrations of hepatic enzymes; Changes in use of statins and fibrates; Changes in use of antihypertensive drugs and hypoglycemic agents; Cardiovascular events; All the above-mentioned primary and secondary outcomes will be evaluated at 12 months
Expected Total Enrollment:  120

Subjects with peripheral arterial disease show an increased cardiovascular risk. It is thought that improving control of cardiovascular risk factors (hypercholesterolemia, hypertension, diabetes, smoking) could be beneficial in reducing their cardiovascular risk. However, usual care of these subjects (mainly at primary care) is not associated with an optimal control of such cardiovascular risk factors. We hypothesise that an intensive multifactorial treatment in a Cardiovascular Risk Unit could improve control of these cardiovascular risk factors. To test this hypothesis we perform a controlled, randomized, open, parallel trial. Subjects are recruited at the Vascular Surgery Unit and are randomised into two groups: 1. usual care (control group); 2. intensive care (intervention group). Randomization is stratified for the presence/absence of diabetes mellitus and with the use of sealed envelopes. Patients assigned to receive usual care (general practitioner with the possibility of being referred to specialists) are compared to those assigned to undergo intensive multifactorial intervention. This intervention involves strict treatment goals (LDL-cholesterol < 100 mg/dl, blood pressure < 130/80, HbA1c < 7 %, no smoking) to be achieved through behavior modification (diet, physical activity, smoking cessation) and a stepwise introduction of pharmacologic therapy for hypercholesterolemia, hypertension and diabetes. This multifactorial intervention is overseen by a multidisciplinary team (endocrinologist, nurse, and dietitian) at the Hospital of Sabadell (Corporación Parc Taulí). The treatment goals are the same for the usual care group and general practitioners caring patients included in this study are informed of these strict treatment goals. Patients in the intensive-therapy receive 6 scheduled individual consultations in one year (baseline and 2,4, 6 and 9 months after their inclusion).Primary and secondary outcomes are evaluated at 12 months after their inclusion.

Ages Eligible for Study:  45 Years   -   80 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Arm-ankle index < 0.85 and > 0.40 in at least one leg

Exclusion Criteria:

• Advanced peripheral arterial disease (arm-ankle index < 0.40 or amputation)
• Peripheral arterial disease of non-atherosclerotic origin (e.g. vasculitis)
• Heart failure (NYHA III or IV)
• End-stage renal disease
• Atrial fibrillation
• Active peptic ulcer disease
• Blood coagulation disorders
• Platelets disorders
• Cancer
• History of rhabdomyolysis
• Treatment with immunosuppressant agents (e.g. cyclosporine, glucocorticoids)
• Excessive intake of alcohol (> 280 gr/week)
• Institutionalized patients

Spain, Barcelona
      Hospital de Sabadell, Sabadell,  Barcelona,  08208,  Spain

Study chairs or principal investigators

José-Miguel González-Clemente, MD, PhD,  Principal Investigator,  Department of Diabetes, Endocrinology and Nutrition. Hospital de Sabadell   
Dídac Mauricio, MD, PhD,  Study Chair,  Department of Diabetes, Endocrinology and Metabolism. Hospital de Sabadell   

Study ID Numbers:  2003020
Last Updated:  September 2, 2005
Record first received:  September 1, 2005
ClinicalTrials.gov Identifier:  NCT00144937
Health Authority: Spain: Spanish Agency of Medicines
ClinicalTrials.gov processed this record on 2005-09-13