Comprehensive Magnetic Resonance of Peripheral Arterial Disease

Peripheral Artery Disease Clinical Trial

Official title:

Comprehensive Magnetic Resonance of Peripheral Arterial Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00587678
• Other study ID #: 10387
• Secondary ID: R01HL075792
• Status: Completed
• Phase: N/A
• First received: December 21, 2007
• Last updated: January 3, 2012
• Start date: January 2006
• Est. completion date: October 2009

Study information

• 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

Clinical Trial 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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Artery Disease
• Peripheral Vascular Diseases

Intervention

Drug:
• Simvastatin
40mg each night
• Ezetimibe
10mg daily
• Simvastatin/Ezetimibe
40mg/10mg each night

Locations

Country	Name	City	State
United States	University of Virgina Health System	Charlottesville	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
University of Virginia	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (6)

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

Outcome

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