N/A
N=85
Comprehensive Magnetic Resonance of Peripheral Arterial Disease
Peripheral Artery Disease
Bottom Line
View on ClinicalTrials.gov: NCT00587678 ↗Enrolled (actual)
85
Serious AEs
0.0%
Results posted
Feb 2012
Primary outcome: Primary: Plaque Volume — 10.5; 10.5; 10.8 cm^3 — p=0.32
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Simvastatin (Drug); Ezetimibe (Drug); Simvastatin/Ezetimibe (Drug)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- University of Virginia
- Primary completion
- Oct 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Plaque Volume |
10.5; 10.5; 10.8 | 0.32 |
| PRIMARY Perfusion Index |
0.34; 0.37; 0.54 | 0.71 |
| PRIMARY Phosphocreatine Recovery Time Constant - the Time it Takes for Phosphocreatine Levels to Recover to Plateau. |
84; 73; 74 | 0.67 |
| SECONDARY Low Density Lipoprotein Cholesterol |
83; 68; 77 | 0.31 |
| SECONDARY Total Cholesterol |
152; 136; 144 | 0.37 |
| SECONDARY High Density Lipoprotein Cholesterol |
44; 46; 43 | 0.78 |
| SECONDARY Triglycerides |
171; 119; 152 | 0.68 |
| SECONDARY Magnetic Resonance Angiographic Index |
0.71; 1.32; 0.63 | <0.05 sig |
| SECONDARY Log Treadmill Exercise Time |
5.92; 5.79; 5.78 | =0.67 |
| SECONDARY 6-minute Walk Distance |
1078; 1038; 1099 | 0.77 |
| SECONDARY V02 - Maximal Oxygen Consumption |
14.8; 12.1; 12.3 | 0.85 |
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.
Eligibility Criteria
Inclusion Criteria
Patients age 30-85 referred to the vascular imaging laboratory with documented evidence of peripheral arterial disease (0.4 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
Data sourced from ClinicalTrials.gov (NCT00587678). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.