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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
Sponsor:
Collaborators:
National Institute of Neurological Disorders and Stroke (NINDS)
University of California, San Francisco
Information provided by (Responsible Party):
Leslie Morrison, University of New Mexico

Study Description
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Brief Summary:
Cerebral cavernous malformations (CCMs) are clusters of abnormal blood vessels in the brain and spine. CCMs can bleed and cause strokes, seizures, and headaches. In some patients, CCMs affect the blood brain barrier (BBB). The BBB is the body's separation of blood and its contents in the brain from the brain tissue itself. Abnormal leakiness or permeability of this barrier can cause disease. We will measure the permeability (leakiness) of the BBB using a magnetic resonance imaging (MRI) technique called dynamic contrast-enhanced MRI (DCEMRI). The purpose of this study is to look at whether statin medications change the permeability (leakiness) of the blood brain barrier in CCM patients. Statin medications are used to lower cholesterol levels and prevent heart attack and stroke. In addition, this medication may decrease the risk of brain hemorrhage or bleeding in patients with CCM. This study will examine whether the permeability of the BBB changes following the administration of simvastatin for three months.

Condition or disease Intervention/treatment Phase
Cavernous Angioma, Familial Cerebral Cavernous Malformations Cerebral Cavernous Hemangioma Drug: Simvastatin Early Phase 1

Study Design
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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

Resource links provided by the National Library of Medicine

Drug Information available for: Simvastatin

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
United States, New Mexico
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, United States, 87131
Sponsors and Collaborators
University of New Mexico
National Institute of Neurological Disorders and Stroke (NINDS)
University of California, San Francisco
Investigators
Principal Investigator: Leslie A Morrison, MD University of New Mexico
Principal Investigator: Blaine Hart, MD University of New Mexico
More Information
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Additional Information:
Angioma Alliance is an organization by and for those affected by cavernous angiomas and their loved ones, health professionals, and researchers.  This link exits the ClinicalTrials.gov site

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