NCT00520312

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
519

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 24, 2007

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2007

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

April 9, 2014

Status Verified

April 1, 2014

Enrollment Period

4.3 years

First QC Date

August 23, 2007

Last Update Submit

April 7, 2014

Conditions

Peripheral Vascular Diseases

Keywords

Peripheral Arterial DiseasePADFunctional ImpairmentMagnetic Resonance Imaging

Outcome Measures

Primary Outcomes (2)

  • Functional Performance: 6-minute walk performance

    Baseline, 12 months, 24 months

  • MRI: Mean Plaque Volume

    Baseline, 24 months

Secondary Outcomes (2)

  • Four meter walking velocity (usual pace), four meter walking velocity (fastest pace), SPPB

    Baseline, 12 months, 24 months

  • MRI: maximum plaque volume, external remodeling, mean percent lumen reduction, maximum percent lumen reduction

    Baseline, 24 months

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Ankle Brachial Index less than 1 in participants

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Related Publications (3)

  • Polonsky TS, Liu K, Tian L, Carr J, Carroll TJ, Berry J, Criqui MH, Ferrucci L, Guralnik JM, Kibbe MR, Kramer CM, Li F, Xu D, Zhao X, Yuan C, McDermott MM. High-risk plaque in the superficial femoral artery of people with peripheral artery disease: prevalence and associated clinical characteristics. Atherosclerosis. 2014 Nov;237(1):169-76. doi: 10.1016/j.atherosclerosis.2014.08.034. Epub 2014 Sep 2.

    PMID: 25240112DERIVED

  • McDermott MM, Carroll TJ, Kibbe M, Kramer CM, Liu K, Guralnik JM, Keeling AN, Criqui MH, Ferrucci L, Yuan C, Tian L, Liao Y, Berry J, Zhao L, Carr J. Proximal superficial femoral artery occlusion, collateral vessels, and walking performance in peripheral artery disease. JACC Cardiovasc Imaging. 2013 Jun;6(6):687-94. doi: 10.1016/j.jcmg.2012.10.024. Epub 2013 May 4.

    PMID: 23647796DERIVED

  • McDermott MM, Liu K, Carr J, Criqui MH, Tian L, Li D, Ferrucci L, Guralnik JM, Kramer CM, Yuan C, Kibbe M, Pearce WH, Berry J, McCarthy W, Liao Y, Xu D, Orozco J, Carroll TJ. Superficial femoral artery plaque, the ankle-brachial index, and leg symptoms in peripheral arterial disease: the walking and leg circulation study (WALCS) III. Circ Cardiovasc Imaging. 2011 May;4(3):246-52. doi: 10.1161/CIRCIMAGING.110.962183. Epub 2011 Mar 24.

    PMID: 21436300DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Peripheral Vascular DiseasesPeripheral Arterial Disease

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesAtherosclerosisArteriosclerosisArterial Occlusive Diseases

Study Officials

  • Mary M. McDermott, MD

    Northwestern University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 23, 2007

First Posted

August 24, 2007

Study Start

October 1, 2007

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

April 9, 2014

Record last verified: 2014-04

Locations

US(1)