Multifactorial Intervention on Cardiovascular Risk Factors in Subjects With Peripheral Arterial Disease

Hospital de Sabadell

Status and phase: Unknown; Phase 4

Conditions: Hypertension; Hypercholesterolemia; Diabetes Mellitus; Peripheral Arterial Disease; Smoking

Treatments: Drug: Stepwise therapy for dyslipidemia, hypertension and diabetes; Behavioral: Increase in physical activity; Behavioral: Dietary recommendations; Behavioral: Smoking cessation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00144937

2003020

Details and patient eligibility

About

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

Full description

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.

Sex: All

Ages: 45 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Educational/Counseling/Training

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)