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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00144937
Recruitment Status : Unknown
Verified September 2005 by Hospital de Sabadell.
Recruitment status was:  Active, not recruiting
First Posted : September 5, 2005
Last Update Posted : September 5, 2005
Bristol-Myers Squibb
Information provided by:
Hospital de Sabadell

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

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Hypercholesterolemia Hypertension Diabetes Mellitus Smoking Drug: Stepwise therapy for dyslipidemia, hypertension and diabetes Behavioral: Dietary recommendations Behavioral: Increase in physical activity Behavioral: Smoking cessation Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Educational/Counseling/Training
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).
Study Start Date : March 2003
Study Completion Date : August 2005

Resource links provided by the National Library of Medicine

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

Secondary Outcome Measures :
  1. Decrease in basal glycaemia and HbA1c(only subjects with diabetes)
  2. Lowering of serum triglycerides and total cholesterol.
  3. Increase in serum HDL cholesterol
  4. Improvement in cardiovascular risk (Framingham Score and UKPDS engine)
  5. Weight reduction
  6. Increase in physical activity
  7. Changes in dietary intake
  8. Smoking cessation
  9. Improvement in health-related quality of life (SF-36)
  10. Improvement of intermittent claudication
  11. Improvement of arm-ankle index
  12. Effect of control of cardiovascular risk factors on metabolic and inflammatory markers associated with cardiovascular disease
  13. Changes in serum concentrations of hepatic enzymes
  14. Changes in use of statins and fibrates
  15. Changes in use of antihypertensive drugs and hypoglycemic agents
  16. Cardiovascular events
  17. All the above-mentioned primary and secondary outcomes will be evaluated at 12 months

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00144937

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Hospital de Sabadell
Sabadell, Barcelona, Spain, 08208
Sponsors and Collaborators
Hospital de Sabadell
Bristol-Myers Squibb
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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

Layout table for additonal information Identifier: NCT00144937     History of Changes
Other Study ID Numbers: 2003020
First Posted: September 5, 2005    Key Record Dates
Last Update Posted: September 5, 2005
Last Verified: September 2005

Additional relevant MeSH terms:
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Diabetes Mellitus
Peripheral Arterial Disease
Peripheral Vascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Lipid Metabolism Disorders
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases