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Comprehensive Magnetic Resonance of Peripheral Arterial Disease

Primary Purpose

Peripheral Artery Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Simvastatin
Ezetimibe
Simvastatin/Ezetimibe
Sponsored by
University of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Artery Disease focused on measuring PAD

Eligibility Criteria

30 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • University of Virgina Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Randomized

Ezetemibe

Arm Description

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

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

Outcomes

Primary Outcome Measures

Plaque Volume
SFA plaque volume
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.
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.

Secondary Outcome Measures

Low Density Lipoprotein Cholesterol
Total Cholesterol
High Density Lipoprotein Cholesterol
Triglycerides
Magnetic Resonance Angiographic Index
MRA index is a measure of angiographic severity of disease. 0 = no disease and 4 is severe disease.
Log Treadmill Exercise Time
6-minute Walk Distance
V02 - Maximal Oxygen Consumption

Full Information

First Posted
December 21, 2007
Last Updated
July 20, 2017
Sponsor
University of Virginia
Collaborators
National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT00587678
Brief Title
Comprehensive Magnetic Resonance of Peripheral Arterial Disease
Official Title
Comprehensive Magnetic Resonance of Peripheral Arterial Disease
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia
Collaborators
National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Artery Disease
Keywords
PAD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
85 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Randomized
Arm Type
Experimental
Arm Description
Patients are imaged at baseline and randomized to Simvistatin 40 mg each night or Simvistatin 40mg/Zetia 10mg each night for 2 years
Arm Title
Ezetemibe
Arm Type
Experimental
Arm Description
Patients are imaged at baseline and treated with ezetimibe 10mg each night for 2 years.
Intervention Type
Drug
Intervention Name(s)
Simvastatin
Other Intervention Name(s)
Zocor
Intervention Description
40mg each night
Intervention Type
Drug
Intervention Name(s)
Ezetimibe
Other Intervention Name(s)
Zetia
Intervention Description
10mg daily
Intervention Type
Drug
Intervention Name(s)
Simvastatin/Ezetimibe
Other Intervention Name(s)
Vytorin
Intervention Description
40mg/10mg each night
Primary Outcome Measure Information:
Title
Plaque Volume
Description
SFA plaque volume
Time Frame
2 years
Title
Perfusion Index
Description
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.
Time Frame
2 years
Title
Phosphocreatine Recovery Time Constant - the Time it Takes for Phosphocreatine Levels to Recover to Plateau.
Description
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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Low Density Lipoprotein Cholesterol
Time Frame
2 years
Title
Total Cholesterol
Time Frame
2 years
Title
High Density Lipoprotein Cholesterol
Time Frame
2 years
Title
Triglycerides
Time Frame
2 years
Title
Magnetic Resonance Angiographic Index
Description
MRA index is a measure of angiographic severity of disease. 0 = no disease and 4 is severe disease.
Time Frame
2 years
Title
Log Treadmill Exercise Time
Time Frame
2 years
Title
6-minute Walk Distance
Time Frame
2 years
Title
V02 - Maximal Oxygen Consumption
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher M Kramer, M.D.
Organizational Affiliation
University of Virginia Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virgina Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16750698
Citation
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.
Results Reference
background
PubMed Identifier
17178683
Citation
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. Erratum In: J Cardiovasc Magn Reson. 2007;9(3):629.
Results Reference
background
PubMed Identifier
17410566
Citation
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.
Results Reference
background
PubMed Identifier
18025990
Citation
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.
Results Reference
background
PubMed Identifier
21570685
Citation
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.
Results Reference
result
PubMed Identifier
21867844
Citation
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.
Results Reference
result
PubMed Identifier
19660694
Citation
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.
Results Reference
derived

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Comprehensive Magnetic Resonance of Peripheral Arterial Disease

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