Multifactor Risk Reduction for Optimal Management of PAD (VIGOR2)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Palo Alto Institute for Research and Education, Inc.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Stanford University
University of California, San Francisco
Information provided by (Responsible Party):
Roberta Oka, Palo Alto Institute for Research and Education, Inc
ClinicalTrials.gov Identifier:
NCT00537225
First received: September 27, 2007
Last updated: July 1, 2013
Last verified: July 2011
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multifactor Risk Reduction for Optimal Management of PAD

Resource links provided by NLM:


Further study details as provided by Palo Alto Institute for Research and Education, Inc:

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 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: A
enhanced usual care
Behavioral: case management
tailored multifactor CVD risk reduction

Detailed Description:

in progress

  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:

  1. Age 50 years or older with one or more CVD risk factor
  2. PAD secondary to atherosclerosis with significant claudication
  3. 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
  4. Ankle-brachial index (ABI) < 0.90
  5. In diabetics ABI is inaccurate, in which case, we will substitute toe pressures < 60 mmHg
  6. ABI one minute after exercise is at least 20% lower than index leg resting ABI
  7. Capable of walking at least 50 feet
  8. Primary limitation to walking is claudication, not coexisting conditions such as severe CAD, uncontrolled hypertension, pulmonary disease, severe arthritis, or orthopedic conditions
  9. Difference of walking time between two consecutive (of four) baseline treadmill tests must be < 25%.

Exclusion Criteria:

Exclusion criteria include:

  1. Active malignancy or tumor or other condition that would severely limit life expectancy
  2. 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)
  3. Residence in a long-term institutional setting
  4. Psychiatric disorders with currently active manifestations
  5. Uncontrolled metabolic disorders (renal failure, liver failure, thyrotoxicosis)
  6. Active symptoms suggestive of an acute coronary syndrome or decompensated heart failure
  7. Lack of phone access (either by self or through neighbors/family members)
  8. Other specified circumstances incompatible with case-management (i.e., plan to move away from area)
  9. Presence of another household member or first-degree relative already enrolled in the study
  10. Current enrollment in another clinical trial
  11. Regular participation in an exercise program for at least 3 months prior to study entry.
  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: NCT00537225

Sponsors and Collaborators
Palo Alto Institute for Research and Education, Inc
Stanford University
University of California, San Francisco
Investigators
Principal Investigator: Roberta K Oka, ANP, DNSc PAIRE
  More Information

No publications provided by Palo Alto Institute for Research and Education, Inc

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Roberta Oka, Associate Chief Nurse, Research, Palo Alto Institute for Research and Education, Inc
ClinicalTrials.gov Identifier: NCT00537225     History of Changes
Other Study ID Numbers: 5RO1NR9197-2
Study First Received: September 27, 2007
Last Updated: July 1, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Palo Alto Institute for Research and Education, Inc:
peripheral arterial disease
walking time
lifestyle modification
cardiovascular risk reduction
exercise
diet
claudication

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 28, 2014