NCT00587678

Brief Summary

The purpose of this study is to develop new ways of imaging fatty blockages in the leg arteries to improve upon techniques used now and to develop new ways of understanding how new treatments may affect the disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
85

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2006

Longer than P75 for not_applicable

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

Study Start

First participant enrolled

January 1, 2006

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

December 21, 2007

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 7, 2008

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

February 3, 2012

Completed
Last Updated

August 21, 2017

Status Verified

July 1, 2017

Enrollment Period

3.8 years

First QC Date

December 21, 2007

Results QC Date

August 2, 2011

Last Update Submit

July 20, 2017

Conditions

Peripheral Artery Disease

Keywords

PAD

Outcome Measures

Primary Outcomes (3)

  • Plaque Volume

    SFA plaque volume

    2 years

  • Perfusion Index

    Perfusion index is a MRI measure of calf muscle perfusion indexed to the arterial input. The value is between 0 and 1 with 0 being worst and 1 being best.

    2 years

  • Phosphocreatine Recovery Time Constant - the Time it Takes for Phosphocreatine Levels to Recover to Plateau.

    Phosphocreatine recovery time constant is the time it takes for phosphocreatine levels to recover to plateau after the completion of exercise. This ranges from 20 to 1000 seconds. 20-40 seconds is normal and any value over 40 seconds is abnormal.

    2 years

Secondary Outcomes (8)

  • Low Density Lipoprotein Cholesterol

    2 years

  • Total Cholesterol

    2 years

  • High Density Lipoprotein Cholesterol

    2 years

  • Triglycerides

    2 years

  • Magnetic Resonance Angiographic Index

    2 years

  • +3 more secondary outcomes

Study Arms (2)

Randomized

EXPERIMENTAL

Patients are imaged at baseline and randomized to Simvistatin 40 mg each night or Simvistatin 40mg/Zetia 10mg each night for 2 years

Drug: SimvastatinDrug: Simvastatin/Ezetimibe

Ezetemibe

EXPERIMENTAL

Patients are imaged at baseline and treated with ezetimibe 10mg each night for 2 years.

Drug: Ezetimibe

Interventions

SimvastatinDRUG

40mg each night

Also known as: Zocor
Randomized
EzetimibeDRUG

10mg daily

Also known as: Zetia
Ezetemibe
Simvastatin/EzetimibeDRUG

40mg/10mg each night

Also known as: Vytorin
Randomized

Eligibility Criteria

Age30 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients age 30-85 referred to the vascular imaging laboratory with documented evidence of peripheral arterial disease (0.4\<ABI\<0.9) 96 Normal healthy subjects ages 30-85

You may not qualify if:

  • Age\<30, \>85
  • GFR less than 45mL/min based on a serum creatinine drawn within 90 days of the MRI:
  • Pregnancy Contraindications to a magnetic resonance examination
  • Intracranial clips
  • Implantable pacemaker and defibrillator
  • Cochlear or intraocular implants
  • Claustrophobia
  • Any metallic implant not listed as magnetic resonance compatible in Shellock F.G ---Pocket Guide to Magnetic Resonance Procedures and Metallic Objects, Update 2000. Lippincott, Williams and Wilkins

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Virgina Health System

Charlottesville, Virginia, 22908, United States

Location

Related Publications (7)

  • Isbell DC, Berr SS, Toledano AY, Epstein FH, Meyer CH, Rogers WJ, Harthun NL, Hagspiel KD, Weltman A, Kramer CM. Delayed calf muscle phosphocreatine recovery after exercise identifies peripheral arterial disease. J Am Coll Cardiol. 2006 Jun 6;47(11):2289-95. doi: 10.1016/j.jacc.2005.12.069. Epub 2006 May 15.

    PMID: 16750698BACKGROUND

  • Isbell DC, Meyer CH, Rogers WJ, Epstein FH, DiMaria JM, Harthun NL, Wang H, Kramer CM. Reproducibility and reliability of atherosclerotic plaque volume measurements in peripheral arterial disease with cardiovascular magnetic resonance. J Cardiovasc Magn Reson. 2007;9(1):71-6. doi: 10.1080/10976640600843330.

    PMID: 17178683BACKGROUND

  • Isbell DC, Epstein FH, Zhong X, DiMaria JM, Berr SS, Meyer CH, Rogers WJ, Harthun NL, Hagspiel KD, Weltman A, Kramer CM. Calf muscle perfusion at peak exercise in peripheral arterial disease: measurement by first-pass contrast-enhanced magnetic resonance imaging. J Magn Reson Imaging. 2007 May;25(5):1013-20. doi: 10.1002/jmri.20899.

    PMID: 17410566BACKGROUND

  • Kramer CM. Peripheral arterial disease assessment: wall, perfusion, and spectroscopy. Top Magn Reson Imaging. 2007 Oct;18(5):357-69. doi: 10.1097/rmr.0b013e31815d064c.

    PMID: 18025990BACKGROUND

  • West AM, Anderson JD, Meyer CH, Epstein FH, Wang H, Hagspiel KD, Berr SS, Harthun NL, DiMaria JM, Hunter JR, Christopher JM, Chew JD, Winberry GB, Kramer CM. The effect of ezetimibe on peripheral arterial atherosclerosis depends upon statin use at baseline. Atherosclerosis. 2011 Sep;218(1):156-62. doi: 10.1016/j.atherosclerosis.2011.04.005. Epub 2011 Apr 16.

    PMID: 21570685RESULT

  • West AM, Anderson JD, Epstein FH, Meyer CH, Wang H, Hagspiel KD, Berr SS, Harthun NL, Weltman AL, Dimaria JM, Hunter JR, Christopher JM, Kramer CM. Low-density lipoprotein lowering does not improve calf muscle perfusion, energetics, or exercise performance in peripheral arterial disease. J Am Coll Cardiol. 2011 Aug 30;58(10):1068-76. doi: 10.1016/j.jacc.2011.04.034.

    PMID: 21867844RESULT

  • Anderson JD, Epstein FH, Meyer CH, Hagspiel KD, Wang H, Berr SS, Harthun NL, Weltman A, Dimaria JM, West AM, Kramer CM. Multifactorial determinants of functional capacity in peripheral arterial disease: uncoupling of calf muscle perfusion and metabolism. J Am Coll Cardiol. 2009 Aug 11;54(7):628-35. doi: 10.1016/j.jacc.2009.01.080.

    PMID: 19660694DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

SimvastatinEzetimibeEzetimibe, Simvastatin Drug Combination

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

LovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAzetidinesAzetinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDrug CombinationsPharmaceutical Preparations

Results Point of Contact

Title
Dr Christopher Kramer
Organization
University of Virginia
434-243-0736

Study Officials

  • Christopher M Kramer, M.D.

    University of Virginia Health System

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Radiology and Medicine

Study Record Dates

First Submitted

December 21, 2007

First Posted

January 7, 2008

Study Start

January 1, 2006

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

August 21, 2017

Results First Posted

February 3, 2012

Record last verified: 2017-07

Locations

US(1)