Peripheral Artery Disease Clinical Trial
Official title:
Comprehensive Magnetic Resonance of Peripheral Arterial Disease
Verified date | January 2012 |
Source | University of Virginia |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 85 |
Est. completion date | October 2009 |
Est. primary completion date | October 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 30 Years to 85 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Virgina Health System | Charlottesville | Virginia |
Lead Sponsor | Collaborator |
---|---|
University of Virginia | National Institutes of Health (NIH) |
United States,
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. Epub 2006 May 15. — View 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. — View 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. Erratum in: J Cardiovasc Magn Reson. 2007;9(3):629. — View Citation
Kramer CM. Peripheral arterial disease assessment: wall, perfusion, and spectroscopy. Top Magn Reson Imaging. 2007 Oct;18(5):357-69. — View 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 performanc — View 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 baselin — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Plaque Volume | SFA plaque volume | 2 years | No |
Primary | 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 | No |
Primary | 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 | No |
Secondary | Low Density Lipoprotein Cholesterol | 2 years | No | |
Secondary | Total Cholesterol | 2 years | No | |
Secondary | High Density Lipoprotein Cholesterol | 2 years | No | |
Secondary | Triglycerides | 2 years | No | |
Secondary | Magnetic Resonance Angiographic Index | MRA index is a measure of angiographic severity of disease. 0 = no disease and 4 is severe disease. | 2 years | No |
Secondary | Log Treadmill Exercise Time | 2 years | No | |
Secondary | 6-minute Walk Distance | 2 years | No | |
Secondary | V02 - Maximal Oxygen Consumption | 2 years | No |
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