Multifactor Risk Reduction for Optimal Management of PAD - Full Text View

Purpose

Patients with peripheral arterial disease (PAD) experience significant functional limitations due to ischemic symptoms (claudication) and are at high risk for CVD morbidity and mortality resulting from untreated cardiovascular disease (CVD) risk factors and aggressive atherosclerosis. The overall Goal of this randomized controlled clinical trial is to examine the synergistic effect of a multifactor risk reduction on walking distance, blood flow and quality of life in 300 patients with PAD.

Specifically, we will compare the effects of 24 months of a novel, yet well-tested multiple risk factor reduction program, the Health Education and Risk Reduction Training (HEAR2T) Program for PAD versus enhanced standard care on: 1) symptom limited walking distance as assessed by treadmill exercise testing and walking impairment questionnaire; 2) endothelial function as measured by flow mediated vasodilation (FMVD) via brachial artery ultrasound. We will also explore the association between FMVD and decreased oxidative stress (as measured by oxygen radical absorbance capacity and urinary isoprostanes) and reduced degradation of nitric oxide (NO) and/or increased NO biosynthesis (as measured by urine nitrogen oxide, plasma nitrogen oxide, plasma asymmetric dimethylarginine, plasma, urine and platelet cyclic GMP).

Secondary hypotheses examine the association between reducing CVD risk factors, improved endothelial function, increased walking distance, improved quality of life and number of metabolic syndrome abnormalities in PAD patients.

Significance. This study will contribute to evidence on the efficacy of multiple risk factor reduction on improving physical function and quality of life in the understudied, elderly PAD patient. This study will also provide preliminary evidence for the biological basis for the efficacy of multifactor risk reduction in restoring vascular homeostasis, critical because of its role in antiatherogenesis and maintaining vasoreactivity, both necessary for slowing the progression of atherosclerosis.

Condition	Intervention
Peripheral Arterial Disease	Behavioral: case management

MedlinePlus related topics:

Exercise and Physical Fitness

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment

Official Title:	Multifactor Risk Reduction for Optimal Management of PAD

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:

walking time [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

quality of life, biomarkers of CVD risk, endothelial function [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	300
Study Start Date:	September 2006
Estimated Study Completion Date:	June 2011
Estimated Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Placebo Comparator enhanced usual care	Behavioral: case management tailored multifactor CVD risk reduction

Eligibility

Ages Eligible for Study:	50 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects eligible for this study include:

Age 50 years or older with one or more CVD risk factor
PAD secondary to atherosclerosis with significant claudication
Claudication is defined as pain, ache, cramp, numbness or severe fatigue of muscles of one or both lower extremities, reproducibly provoked by walking causing the patient to slow or stop walking pace
Ankle-brachial index (ABI) < 0.90
In diabetics ABI is inaccurate, in which case, we will substitute toe pressures < 60 mmHg
ABI one minute after exercise is at least 20% lower than index leg resting ABI
Capable of walking at least 50 feet
Primary limitation to walking is claudication, not coexisting conditions such as severe CAD, uncontrolled hypertension, pulmonary disease, severe arthritis, or orthopedic conditions
Difference of walking time between two consecutive (of four) baseline treadmill tests must be < 25%.

Exclusion Criteria:

Exclusion criteria include:

Active malignancy or tumor or other condition that would severely limit life expectancy
Any type of major surgery during the last 3 months (i.e. aortic or lower extremity arterial surgery, angioplasty, or lumbar sympathectomy, leg amputation above the ankle)
Residence in a long-term institutional setting
Psychiatric disorders with currently active manifestations
Uncontrolled metabolic disorders (renal failure, liver failure, thyrotoxicosis)
Active symptoms suggestive of an acute coronary syndrome or decompensated heart failure
Lack of phone access (either by self or through neighbors/family members)
Other specified circumstances incompatible with case-management (i.e., plan to move away from area)
Presence of another household member or first-degree relative already enrolled in the study
Current enrollment in another clinical trial
Regular participation in an exercise program for at least 3 months prior to study entry.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00537225

Contacts


Contact: Roberta K Oka, ANP, DNSc	415-514-3407	roberta.oka@nursing.ucsf.edu

Locations


United States, California
	University of California	Recruiting
	San Francisco, California, United States, 94143-0608
	Principal Investigator: Roberta K Oka, DNSc

Sponsors and Collaborators

University of California, San Francisco

Department of Veterans Affairs

Stanford University

Investigators


Principal Investigator:	Roberta K Oka, ANP, DNSc	University of California, San Francisco

More Information

Responsible Party:	UCSF ( Joan Kaiser )
Study ID Numbers:	5RO1NR9197-2, NIH 5RO1NR9197-2
First Received:	September 27, 2007
Last Updated:	May 19, 2008
ClinicalTrials.gov Identifier:	NCT00537225
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, San Francisco:

peripheral arterial disease

walking time

lifestyle modification

cardiovascular risk reduction

exercise

diet

claudication

Study placed in the following topic categories:

Peripheral Vascular Diseases

Vascular Diseases

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 24, 2008

Sponsors and Collaborators:	University of California, San Francisco Department of Veterans Affairs Stanford University
Information provided by:	University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT00537225