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Completed

NCT Number: NCT00587678

Comprehensive Magnetic Resonance of Peripheral Arterial Disease

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.

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Key information

Conditions

Peripheral Artery Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Arterial Disease Peripheral Vascular Diseases Vascular Diseases

Age range

30 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Virgina Health System

Charlottesville, Virginia, 22908, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

simvastatin

Drug

40mg each night

Other names: Zocor

ezetimibe

Drug

10mg daily

Other names: Zetia

Simvastatin/Ezetimibe

Drug

40mg/10mg each night

Other names: Vytorin

Primary outcomes

  1. Plaque Volume

    Time frame: 2 years

    SFA plaque volume

  2. Perfusion Index

    Time frame: 2 years

    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.

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

    Time frame: 2 years

    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 outcomes

  1. Low Density Lipoprotein Cholesterol

    Time frame: 2 years

  2. Total Cholesterol

    Time frame: 2 years

  3. High Density Lipoprotein Cholesterol

    Time frame: 2 years

  4. Triglycerides

    Time frame: 2 years

  5. Magnetic Resonance Angiographic Index

    Time frame: 2 years

    MRA index is a measure of angiographic severity of disease. 0 = no disease and 4 is severe disease.

  6. Log Treadmill Exercise Time

    Time frame: 2 years

  7. 6-minute Walk Distance

    Time frame: 2 years

  8. V02 - Maximal Oxygen Consumption

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)
  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Jan 7, 2008
Registry last updated
Aug 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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