Comprehensive Magnetic Resonance of Peripheral Arterial Disease
This study has been completed.
Sponsor:
University of Virginia
Collaborator:
Information provided by (Responsible Party):
Christopher M. Kramer MD, University of Virginia
ClinicalTrials.gov Identifier:
NCT00587678
First received: December 21, 2007
Last updated: January 3, 2012
Last verified: January 2012
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| Tracking Information | |||||
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| First Received Date ICMJE | December 21, 2007 | ||||
| Last Updated Date | January 3, 2012 | ||||
| Start Date ICMJE | January 2006 | ||||
| Primary Completion Date | October 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
We hypothesize that multi-modality magnetic resonance can test the efficacy of lipid lowering therapy therapy on the vessel wall, atherosclerotic plaque, and skeletal muscle perfusion and energetics in PAD [ Time Frame: 2 years ] [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT00587678 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Comprehensive Magnetic Resonance of Peripheral Arterial Disease | ||||
| Official Title ICMJE | Comprehensive Magnetic Resonance of Peripheral Arterial Disease | ||||
| Brief 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Peripheral Artery Disease | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 85 | ||||
| Completion Date | October 2009 | ||||
| Primary Completion Date | October 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | 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
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| Gender | Both | ||||
| Ages | 30 Years to 85 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00587678 | ||||
| Other Study ID Numbers ICMJE | 10387, R01 HL75792 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Christopher M. Kramer MD, University of Virginia | ||||
| Study Sponsor ICMJE | University of Virginia | ||||
| Collaborators ICMJE | National Institutes of Health (NIH) | ||||
| Investigators ICMJE |
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| Information Provided By | University of Virginia | ||||
| Verification Date | January 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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