Mechanisms of Disability in Peripheral Arterial Disease

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00046592
First received: September 30, 2002
Last updated: January 18, 2008
Last verified: January 2008
  Purpose

To determine the mechanisms by which atherosclerotic peripheral artery disease (PAD) causes functional impairment and to define the degree to which peripheral artery disease associated pathophysiologic findings change over time.


Condition
Cardiovascular Diseases
Arterial Occlusive Diseases
Peripheral Vascular Diseases

Study Type: Observational

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: August 2002
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Detailed Description:

BACKGROUND:

Research demonstrates that men and women with lower extremity peripheral arterial disease (PAD) have poorer functioning than men and women without PAD. Preliminary data also indicate that more severe PAD at baseline, as measured by the ankle brachial index (ABI), is associated with a greater incidence of functional loss. However, the pathophysiologic mechanisms in the lower extremities responsible for PAD-related functional impairment and functional loss are not well defined.

DESIGN NARRATIVE:

The study cohort will consist of 790 individuals identified from three Chicago-area medical centers, of whom 500 will have PAD. Participants will undergo a baseline and two annual follow-up visits. Pathophysiologic findings in the lower extremities refer to reduced muscle mass, reduced muscle quality, and reduced peripheral sensory and motor function. Quality of muscle tissue is defined as the ratio of muscle force to muscle mass. Muscle mass will be measured with Computed Tomography (CT). Peripheral nerve function will be determined using surface electroneurography (ENG). Lower extremity functional measures will consist of measures pertinent to functioning during daily living and include six minute walk distance, seven-day physical activity level (assessed by accelerometer), walking speed, balance tests, and lower extremity muscle power.

The cross-sectional study will test the hypotheses that a) chronic lower extremity arterial ischemia is associated with specific pathophysiologic findings in lower extremity muscle and nerve and that b) these ischemia-related pathophysiologic findings are associated with lower extremity functional limitation.The longitudinal study will test the hypotheses that a) greater baseline lower extremity arterial ischemia as measured by ABI is associated with greater progression of pathophysiologic findings over two year follow-up and that b) greater ischemia-related pathophysiologic findings in the legs at baseline is associated with greater functional decline over two year follow up. Results will be used to develop interventions designed to improve lower extremity functioning and prevent functional decline in persons with PAD.

  Eligibility

Ages Eligible for Study:   59 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

No eligibility criteria

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00046592

Sponsors and Collaborators
Investigators
Investigator: Mary McDermott Northwestern University Feinberg School of Medicine
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00046592     History of Changes
Other Study ID Numbers: 1185
Study First Received: September 30, 2002
Last Updated: January 18, 2008
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on October 16, 2014