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

September 1, 2005 updated by: Hospital de Sabadell

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).

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Educational/Counseling/Training
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Cardiovascular events
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
All the above-mentioned primary and secondary outcomes will be evaluated at 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Sabadell

Collaborators

Bristol-Myers Squibb

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2003

Study Completion

August 1, 2005

Study Registration Dates

First Submitted

September 1, 2005

First Submitted That Met QC Criteria

September 1, 2005

First Posted (Estimate)

September 5, 2005

Study Record Updates

Last Update Posted (Estimate)

September 5, 2005

Last Update Submitted That Met QC Criteria

September 1, 2005

Last Verified

September 1, 2005

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2003020

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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