Overview

This trial is active, not recruiting.

Conditions peripheral arterial disease, hypercholesterolemia, hypertension, diabetes mellitus, smoking
Treatments stepwise therapy for dyslipidemia, hypertension and diabetes, dietary recommendations, increase in physical activity, smoking cessation
Phase phase 4
Sponsor Hospital de Sabadell
Collaborator Bristol-Myers Squibb
Start date March 2003
End date August 2005
Trial size 120 participants
Trial identifier NCT00144937, 2003020

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose educational/counseling/training

Primary Outcomes

Measure
Lowering of LDL cholesterol concentrations and blood pressure levels (at 12 months). Increase in use of antiplatelet agents (at 12 months)
time frame:

Secondary Outcomes

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

Eligibility Criteria

Male or female participants from 45 years up to 80 years old.

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

Additional Information

Official title A Randomized Controlled Trial Comparing Usual Care With a Multifactorial Intensified Intervention on Cardiovascular Risk Factors in Subjects With Arterial Peripheral Disease With and Without Diabetes. The Taulí Intervention Program (TIP).
Principal investigator José-Miguel González-Clemente, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2005.
Information provided to ClinicalTrials.gov by Hospital de Sabadell.