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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Mary McDermott, Northwestern University
ClinicalTrials.gov Identifier:
NCT00520312
First received: August 23, 2007
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

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
Peripheral Vascular Diseases

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Magnetic Resonance in Peripheral Arterial Disease

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Functional Performance: 6-minute walk performance [ Time Frame: Baseline, 12 months, 24 months ] [ Designated as safety issue: No ]
  • MRI: Mean Plaque Volume [ Time Frame: Baseline, 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Four meter walking velocity (usual pace), four meter walking velocity (fastest pace), SPPB [ Time Frame: Baseline, 12 months, 24 months ] [ Designated as safety issue: No ]
  • MRI: maximum plaque volume, external remodeling, mean percent lumen reduction, maximum percent lumen reduction [ Time Frame: Baseline, 24 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Plasma, serum, and whole blood samples are stored for future analysis


Enrollment: 519
Study Start Date: October 2007
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Ankle Brachial Index less than 1 in participants

Criteria

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
  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: NCT00520312

Locations
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Mary M. McDermott, MD Northwestern University
  More Information

No publications provided by Northwestern University

Additional 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, R01 HL083064-01A2
Study First Received: August 23, 2007
Last Updated: April 7, 2014
Health Authority: United States: Federal Government

Keywords provided by Northwestern University:
Peripheral Arterial Disease
PAD
Functional Impairment
Magnetic Resonance Imaging

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

ClinicalTrials.gov processed this record on October 23, 2014