Clinical trial NCT00144937: Multifactorial Intervention on Cardiovascular Risk Factors in Subjects With Peripheral Arterial Disease
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Peripheral Arterial Disease
Hypercholesterolemia
Hypertension
Diabetes Mellitus
Smoking
Lead sponsor: Hospital de Sabadell
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
First posted: 2005-09-05
Enrollment: 120
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: ECT

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

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 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

Primary outcomes:
measure: Lowering of LDL cholesterol concentrations and blood pressure levels (at 12 months). Increase in use of antiplatelet agents (at 12 months)
Secondary outcomes:
measure: Decrease in basal glycaemia and HbA1c(only subjects with diabetes)
measure: Lowering of serum triglycerides and total cholesterol.
measure: Increase in serum HDL cholesterol
measure: Improvement in cardiovascular risk (Framingham Score and UKPDS engine)
measure: Weight reduction
measure: Increase in physical activity
measure: Changes in dietary intake
measure: Smoking cessation
measure: Improvement in health-related quality of life (SF-36)
measure: Improvement of intermittent claudication
measure: Improvement of arm-ankle index
measure: Effect of control of cardiovascular risk factors on metabolic and inflammatory markers associated with cardiovascular disease
measure: Changes in serum concentrations of hepatic enzymes
measure: Changes in use of statins and fibrates
measure: Changes in use of antihypertensive drugs and hypoglycemic agents
measure: Cardiovascular events
measure: All the above-mentioned primary and secondary outcomes will be evaluated at 12 months
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Hospital de Sabadell
state: Barcelona
Study officials:
affiliation: Department of Diabetes, Endocrinology and Nutrition. Hospital de Sabadell
name: José-Miguel González-Clemente, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Diabetes, Endocrinology and Metabolism. Hospital de Sabadell
name: Dídac Mauricio, MD, PhD
role: STUDY_CHAIR
References: