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

NCT ID: NCT00144937

Last Updated: 2005-09-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-03-31
• Study Completion Date: 2005-08-31

Brief Summary

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

Detailed 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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: ECT
• Blinding Strategy: NONE

Interventions

Stepwise therapy for dyslipidemia, hypertension and diabetes

Intervention Type: DRUG

Dietary recommendations

Intervention Type: BEHAVIORAL

Increase in physical activity

Intervention Type: BEHAVIORAL

Smoking cessation

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: collaborator

Hospital de Sabadell

OTHER

Sponsor Role: lead

Principal Investigators

José-Miguel González-Clemente, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Diabetes, Endocrinology and Nutrition. Hospital de Sabadell

Dídac Mauricio, MD, PhD

Role: STUDY_CHAIR

Department of Diabetes, Endocrinology and Metabolism. Hospital de Sabadell

Locations

Hospital de Sabadell

Sabadell, Barcelona, Spain

Countries

Spain

Other Identifiers

2003020

Identifier Type: -

Identifier Source: org_study_id