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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Hospital de Sabadell.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by:
Hospital de Sabadell
ClinicalTrials.gov Identifier:
NCT00144937
First received: September 1, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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).

Resource links provided by NLM:


Further study details as provided by Hospital de Sabadell:

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

Secondary Outcome Measures:
  • 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
  • Cardiovascular events
  • All the above-mentioned primary and secondary outcomes will be evaluated at 12 months

Estimated Enrollment: 120
Study Start Date: March 2003
Estimated Study Completion Date: August 2005
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.

  Eligibility

Ages Eligible for Study:   45 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00144937

Locations
Spain
Hospital de Sabadell
Sabadell, Barcelona, Spain, 08208
Sponsors and Collaborators
Hospital de Sabadell
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00144937     History of Changes
Other Study ID Numbers: 2003020
Study First Received: September 1, 2005
Last Updated: September 1, 2005
Health Authority: Spain: Spanish Agency of Medicines

Additional relevant MeSH terms:
Diabetes Mellitus
Hypercholesterolemia
Hypertension
Smoking
Peripheral Arterial Disease
Peripheral Vascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Vascular Diseases
Cardiovascular Diseases
Habits
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on July 24, 2014