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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL075792 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Randomized | Experimental | Patients are imaged at baseline and randomized to Simvistatin 40 mg each night or Simvistatin 40mg/Zetia 10mg each night for 2 years |
|
| Ezetemibe | Experimental | Patients are imaged at baseline and treated with ezetimibe 10mg each night for 2 years. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Simvastatin | Drug | 40mg each night |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Plaque Volume | SFA plaque volume | 2 years |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Low Density Lipoprotein Cholesterol | 2 years | |
| Total Cholesterol | 2 years | |
| High Density Lipoprotein Cholesterol |
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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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| Name | Affiliation | Role |
|---|---|---|
| Christopher M Kramer, M.D. | University of Virginia Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virgina Health System | Charlottesville | Virginia | 22908 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16750698 | Background | 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. doi: 10.1016/j.jacc.2005.12.069. Epub 2006 May 15. | |
| 17178683 | Background | 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. doi: 10.1080/10976640600843330. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Simvastatin 40mg | Statin naive patients randomized to simvastatin 40mg qhs after baseline studies for 2 years |
| FG001 | Simvastatin 40mg/Ezetimibe 10 mg | Statin naive patients randomized to simvastatin 40mg/Ezetimibe 10mg qhs after baseline studies for 2 years |
| FG002 | Ezetimibe 10mg | Open label Ezetimibe 10mg daily begun after baseline studies for 2 years |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Simvastatin 40mg | Statin naive patients randomized to simvastatin 40mg qhs after baseline studies for 2 years |
| BG001 | Simvastatin 40mg/Ezetimibe 10 mg | Statin naive patients randomized to simvastatin 40mg/Ezetimibe 10mg qhs after baseline studies for 2 years |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Plaque Volume | SFA plaque volume | Posted | Mean | Standard Deviation | cm^3 | 2 years |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Simvastatin 40mg | Statin naive patients randomized to simvastatin 40mg qhs after baseline studies for 2 years |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Christopher Kramer | University of Virginia | 434-243-0736 |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D019821 | Simvastatin |
| D000069438 | Ezetimibe |
| D000069499 | Ezetimibe, Simvastatin Drug Combination |
| ID | Term |
|---|---|
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| Ezetimibe |
| Drug |
10mg daily |
|
|
| Simvastatin/Ezetimibe | Drug | 40mg/10mg each night |
|
|
| 2 years |
| Triglycerides | 2 years |
| Magnetic Resonance Angiographic Index | MRA index is a measure of angiographic severity of disease. 0 = no disease and 4 is severe disease. | 2 years |
| Log Treadmill Exercise Time | 2 years |
| 6-minute Walk Distance | 2 years |
| V02 - Maximal Oxygen Consumption | 2 years |
| 17410566 | Background | 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. doi: 10.1002/jmri.20899. |
| 18025990 | Background | Kramer CM. Peripheral arterial disease assessment: wall, perfusion, and spectroscopy. Top Magn Reson Imaging. 2007 Oct;18(5):357-69. doi: 10.1097/rmr.0b013e31815d064c. |
| 21570685 | Result | 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 baseline. Atherosclerosis. 2011 Sep;218(1):156-62. doi: 10.1016/j.atherosclerosis.2011.04.005. Epub 2011 Apr 16. |
| 21867844 | Result | 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 performance in peripheral arterial disease. J Am Coll Cardiol. 2011 Aug 30;58(10):1068-76. doi: 10.1016/j.jacc.2011.04.034. |
| 19660694 | Derived | Anderson JD, Epstein FH, Meyer CH, Hagspiel KD, Wang H, Berr SS, Harthun NL, Weltman A, Dimaria JM, West AM, Kramer CM. Multifactorial determinants of functional capacity in peripheral arterial disease: uncoupling of calf muscle perfusion and metabolism. J Am Coll Cardiol. 2009 Aug 11;54(7):628-35. doi: 10.1016/j.jacc.2009.01.080. |
| BG002 | Ezetimibe 10mg | Open label Ezetimibe 10mg daily begun after baseline studies for 2 years |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Total cholesterol | Mean | Standard Deviation | mg/dl |
|
| Low density lipoprotein cholesterol | Mean | Standard Deviation | mg/dl |
|
| High density lipoprotein cholesterol | Mean | Standard Deviation | mg/dl |
|
| Triglycerides | Mean | Standard Deviation | mg/dl |
|
| Plaque volume | Mean | Standard Deviation | cm^3 |
|
| Total vessel volume | Mean | Standard Deviation | cm^3 |
|
| Lumen volume | Mean | Standard Deviation | cm3 |
|
| Perfusion index | First pass contrast-enhanced MRI measure of exercise calf muscle perfusion | Mean | Standard Deviation | Units on a scale (0 = worst, 1 = best). |
|
| Phosphocreatine recovery time constant | Phosphocreatine recovery time constant measured at peak exercise with 31P magnetic resonance spectroscopy. The range is from 20 to 1000 seconds with 20-40 being normal and higher than 40 abnormal. | Mean | Standard Deviation | seconds |
|
| Magnetic resonance angiographic index | Index of stenoses based on MR angiogram (0=normal, 4=worst possible) | Mean | Standard Deviation | units on a scale (0-4). 0 = normal. |
|
| Log of Treadmill Exercise Time | Mean | Standard Deviation | log of time in seconds |
|
| 6-minute walk distance | Mean | Standard Deviation | feet |
|
| V02 max - maximal oxygen consumption | Measured during treadmill exercise | Mean | Standard Deviation | ml/kg/min |
|
|
|
|
| Secondary | Low Density Lipoprotein Cholesterol | Posted | Mean | Standard Deviation | mg/dl | 2 years |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | Units on a scale (0 = worst, 1 = best) | 2 years |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | seconds | 2 years |
|
|
|
|
| Secondary | Total Cholesterol | Posted | Mean | Standard Deviation | mg/dl | 2 years |
|
|
|
|
| Secondary | High Density Lipoprotein Cholesterol | Posted | Mean | Standard Deviation | mg/dl | 2 years |
|
|
|
|
| Secondary | Triglycerides | Posted | Mean | Standard Deviation | mg/dl | 2 years |
|
|
|
|
| Secondary | Magnetic Resonance Angiographic Index | MRA index is a measure of angiographic severity of disease. 0 = no disease and 4 is severe disease. | Posted | Mean | Standard Deviation | units on scale (0 = normal, 4 = worst) | 2 years |
|
|
|
|
| Secondary | Log Treadmill Exercise Time | Posted | Mean | Standard Deviation | log time in seconds | 2 years |
|
|
|
|
| Secondary | 6-minute Walk Distance | Posted | Mean | Standard Deviation | ft. | 2 years |
|
|
|
|
| Secondary | V02 - Maximal Oxygen Consumption | Posted | Mean | Standard Deviation | ml/min/kg | 2 years |
|
|
|
|
| 0 |
| 24 |
| 0 |
| 22 |
| EG001 | Simvastatin 40mg/Ezetimibe 10 mg | Statin naive patients randomized to simvastatin 40mg/Ezetimibe 10mg qhs after baseline studies for 2 years | 0 | 22 | 0 | 22 |
| EG002 | Ezetimibe 10mg | Open label Ezetimibe 10mg daily begun after baseline studies for 2 years | 0 | 41 | 0 | 41 |
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| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D001384 | Azetidines |
| D001385 | Azetines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
vs. baseline
| 95 |
| Superiority or Other |
vs. baseline
| 95 |
| Superiority or Other |