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

NCT00144937 | Unknown Phase 4

• 1 other identifier: 2003020
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (17)

• 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

Interventions

Stepwise therapy for dyslipidemia, hypertension and diabetes DRUG

Dietary recommendations BEHAVIORAL

Increase in physical activity BEHAVIORAL

Smoking cessation BEHAVIORAL

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Arm-ankle index \< 0.85 and \> 0.40 in at least one leg

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital de Sabadell: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

Hospital de Sabadell

Sabadell, Barcelona, 08208, Spain

Location

MeSH Terms

Conditions

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

Interventions

Exercise

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Glucose Metabolism Disorders; Endocrine System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• José-Miguel González-Clemente, MD, PhD

  Department of Diabetes, Endocrinology and Nutrition. Hospital de Sabadell

  PRINCIPAL INVESTIGATOR

• Dídac Mauricio, MD, PhD

  Department of Diabetes, Endocrinology and Metabolism. Hospital de Sabadell

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: ECT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 1, 2005
• First Posted: September 5, 2005
• Study Start: March 1, 2003
• Study Completion: August 1, 2005
• Last Updated: September 5, 2005

Record last verified: 2005-09

Locations

ES (1)