Comprehensive Magnetic Resonance of Peripheral Arterial Disease
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|ClinicalTrials.gov Identifier: NCT00587678|
Recruitment Status : Completed
First Posted : January 7, 2008
Results First Posted : February 3, 2012
Last Update Posted : August 21, 2017
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Artery Disease||Drug: Simvastatin Drug: Ezetimibe Drug: Simvastatin/Ezetimibe||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||85 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Comprehensive Magnetic Resonance of Peripheral Arterial Disease|
|Study Start Date :||January 2006|
|Actual Primary Completion Date :||October 2009|
|Actual Study Completion Date :||October 2009|
Patients are imaged at baseline and randomized to Simvistatin 40 mg each night or Simvistatin 40mg/Zetia 10mg each night for 2 years
40mg each night
Other Name: Zocor
40mg/10mg each night
Other Name: Vytorin
Patients are imaged at baseline and treated with ezetimibe 10mg each night for 2 years.
Other Name: Zetia
- Plaque Volume [ Time Frame: 2 years ]SFA plaque volume
- 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.
- 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.
- Low Density Lipoprotein Cholesterol [ Time Frame: 2 years ]
- Total Cholesterol [ Time Frame: 2 years ]
- High Density Lipoprotein Cholesterol [ Time Frame: 2 years ]
- Triglycerides [ Time Frame: 2 years ]
- 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.
- Log Treadmill Exercise Time [ Time Frame: 2 years ]
- 6-minute Walk Distance [ Time Frame: 2 years ]
- V02 - Maximal Oxygen Consumption [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00587678
|United States, Virginia|
|University of Virgina Health System|
|Charlottesville, Virginia, United States, 22908|
|Principal Investigator:||Christopher M Kramer, M.D.||University of Virginia Health System|