Permeability MRI in Cerebral Cavernous Malformations Type 1 in New Mexico: Effects of Statins
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ClinicalTrials.gov Identifier: NCT01764451 |
Recruitment Status
:
Completed
First Posted
: January 9, 2013
Last Update Posted
: April 11, 2016
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cavernous Angioma, Familial Cerebral Cavernous Malformations Cerebral Cavernous Hemangioma | Drug: Simvastatin | Early Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 12 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Permeability MRI in Cerebral Cavernous Malformations Type 1 in New Mexico: Effects of Statins |
Study Start Date : | March 2012 |
Actual Primary Completion Date : | January 2016 |
Actual Study Completion Date : | January 2016 |

Arm | Intervention/treatment |
---|---|
Experimental: Simvastatin
20-40 mg tablet taken daily by mouth. Month 1: 20 mg; Months 2 and 3: 40 mg.
|
Drug: Simvastatin
Other Name: Zocor
|
No Intervention: No Treatment |
- Change in blood brain barrier permeability over three months for the treatment group compared to the control group. [ Time Frame: Baseline, Three Months ]We will measure the change in blood brain barrier permeability with dynamic contrast enhanced MRI from baseline to three months. We will compare the change in permeability for a group of CCM patients placed on statin medication (treatment group) with a group of CCM patients not on statin medication (control group).
- Correlation of physiologic permeability data with anatomic lesion data [ Time Frame: Baseline, Three months ]Use dynamic contrast-enhanced MRI to detect abnormalities in brain permeability in CCM patients and correlate with anatomic lesion information.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Diagnosis of cerebral cavernous malformations-common Hispanic mutation (CCM1-CHM)
- Must be willing to travel to the University of New Mexico in Albuquerque, NM for 5 visits over the course of three months.
Exclusion Criteria:
- Incarceration
- Unable to pass MRI safety screening (pregnant females, claustrophics, or those with certain metallic items implanted in their bodies)
- Low kidney function or transplants, an eGFR below 60 mL/min
- Currently taking statin medications or have taken statin medications in the past 6 months
- Known allergy or intolerance to statins
- Known allergy or intolerance to gadolinium
- Liver dysfunction at baseline, AST > 47 and/or ALT > 49
- Consumption of large quantities of alcohol, men who consume more than 2 daily drinks and women who consume more than one daily drink
- CK level of 232 or higher
- Triglycerides greater than or equal to 500.
- Medications: gemfibrozil, cyclosporine, danazol, itraconazole, ketoconazole, posaconazole, ethromycin, clarithomycin, telithromycin, HIV protease inhibitors, nefazoldone, amiodarone, verapamil, dilitiazem, amlodipine, or ranalazine

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): NCT01764451
United States, New Mexico | |
University of New Mexico Health Sciences Center | |
Albuquerque, New Mexico, United States, 87131 |
Principal Investigator: | Leslie A Morrison, MD | University of New Mexico | |
Principal Investigator: | Blaine Hart, MD | University of New Mexico |
Additional Information:
Responsible Party: | Leslie Morrison, Vice Chancellor for Academic Affairs, University of New Mexico |
ClinicalTrials.gov Identifier: | NCT01764451 History of Changes |
Other Study ID Numbers: |
BVMC 6205 U54NS065705 ( U.S. NIH Grant/Contract ) |
First Posted: | January 9, 2013 Key Record Dates |
Last Update Posted: | April 11, 2016 |
Last Verified: | April 2016 |
Keywords provided by Leslie Morrison, University of New Mexico:
Hispanic |
Additional relevant MeSH terms:
Congenital Abnormalities Hemangioma Hemangioma, Cavernous, Central Nervous System Hemangioma, Cavernous Neoplasms, Vascular Tissue Neoplasms by Histologic Type Neoplasms Central Nervous System Vascular Malformations Nervous System Malformations Nervous System Diseases Vascular Malformations Cardiovascular Abnormalities Cardiovascular Diseases |
Hemostatic Disorders Vascular Diseases Hemorrhagic Disorders Hematologic Diseases Simvastatin Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors |