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Magnetic Resonance Imaging to Identify Characteristics of Plaque Build-Up in People With Peripheral Arterial Disease

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ClinicalTrials.gov Identifier: NCT00520312
Recruitment Status : Completed
First Posted : August 24, 2007
Last Update Posted : April 9, 2014
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Mary McDermott, Northwestern University

Brief Summary:
Peripheral arterial disease (PAD) is a disease in which fatty build-up, or "plaque," accumulates in the peripheral arteries. People with PAD often experience leg pain while walking due to reduced blood flow to the legs. This study will use magnetic resonance imaging (MRI) techniques to examine how specific features of plaque build-up in the leg arteries affect walking ability, leg strength, and balance in people with PAD.

Condition or disease
Peripheral Vascular Diseases

Detailed Description:

Plaque build-up caused by atherosclerosis increases the risk of blood clots, heart attack, and stroke. Blockages of plaque can occur in different areas of the body. PAD, a circulatory disorder in which blockages occur in the peripheral arteries, is one manifestation of atherosclerosis. Individuals with PAD experience reduced blood flow to the legs, which may cause leg pain while walking. This study will use MRI techniques to examine how characteristics of plaque build-up in the leg arteries change over time and how this change affects function, walking ability, leg strength, and balance in people with PAD. Results from this study may be used to shape future research studies that will attempt to identify more effective treatments for people with PAD.

This study will enroll people with PAD, as well as a smaller control group of people who do not have PAD. At an initial study visit, study researchers will interview participants to collect information about their medical history, daily activity level, walking ability, and mental functioning. Blood collection and a leg MRI will occur. Also, blood flow to the legs will be measured by comparing blood pressure measurements in the arms and legs. Leg function will be measured through a series of timed walks, leg strength exercises, and muscle power exercises. Questionnaires to assess participants' medical history will be completed by each participant's primary care doctor, and study researchers will review participants' medical records. Participants with knee pain will have a knee x-ray, and participants may wear a small device called an accelerometer for 1 week to monitor physical activity levels. During the second and third study visits, occurring at one and two year follow-up, blood flow, leg function, and leg strength will be measured. If participants cannot attend either study visit, researchers may visit participants at their home or conduct an interview over the phone. Study researchers may contact participants by phone once or twice a year for follow-up.

Study Type : Observational
Actual Enrollment : 519 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Magnetic Resonance in Peripheral Arterial Disease
Study Start Date : October 2007
Primary Completion Date : January 2012
Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Functional Performance: 6-minute walk performance [ Time Frame: Baseline, 12 months, 24 months ]
  2. MRI: Mean Plaque Volume [ Time Frame: Baseline, 24 months ]

Secondary Outcome Measures :
  1. Four meter walking velocity (usual pace), four meter walking velocity (fastest pace), SPPB [ Time Frame: Baseline, 12 months, 24 months ]
  2. MRI: maximum plaque volume, external remodeling, mean percent lumen reduction, maximum percent lumen reduction [ Time Frame: Baseline, 24 months ]

Biospecimen Retention:   Samples With DNA
Plasma, serum, and whole blood samples are stored for future analysis

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Ankle Brachial Index less than 1 in participants

Inclusion Criteria:

  • For participants with PAD: lowest leg ankle-brachial index (ABI) less than or equal to 0.999
  • For participants in the control group: lowest ABI between 1.00 to 1.30

Exclusion Criteria:

  • Foot amputation, leg amputation, or gangrene
  • Recent liver transplantation
  • Requires oxygen on ambulation
  • End stage renal disease
  • Confined to a wheelchair
  • Lives in a nursing home
  • Low life expectancy
  • Mini-Mental Status Exam (MMSE) score of less than 23 out of 30
  • Communication difficulty due to language barriers
  • Inability to tolerate MRI testing for any reason
  • Six-minute walk performance limited primarily by pulmonary disease, legal blindness, or severe lower extremity arthritis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00520312

United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Mary M. McDermott, MD Northwestern University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mary McDermott, Principal Investigator, Northwestern University
ClinicalTrials.gov Identifier: NCT00520312     History of Changes
Other Study ID Numbers: 1396
R01HL083064-01A2 ( U.S. NIH Grant/Contract )
First Posted: August 24, 2007    Key Record Dates
Last Update Posted: April 9, 2014
Last Verified: April 2014

Keywords provided by Mary McDermott, Northwestern University:
Peripheral Arterial Disease
Functional Impairment
Magnetic Resonance Imaging

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