Permeability MRI in Cerebral Cavernous Malformations Type 1 in New Mexico: Effects of Statins

Brief Title

Permeability MRI in Cerebral Cavernous Malformations Type 1 in New Mexico: Effects of Statins

Official Title

Permeability MRI in Cerebral Cavernous Malformations Type 1 in New Mexico: Effects of Statins

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.
    


Study Phase

Early Phase 1

Study Type

Interventional


Primary Outcome

Change in blood brain barrier permeability over three months for the treatment group compared to the control group.

Secondary Outcome

 Correlation of physiologic permeability data with anatomic lesion data

Condition

Cavernous Angioma, Familial

Intervention

Simvastatin

Study Arms / Comparison Groups

 Simvastatin
Description:  20-40 mg tablet taken daily by mouth. Month 1: 20 mg; Months 2 and 3: 40 mg.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

12

Start Date

March 2012

Completion Date

January 2016

Primary Completion Date

January 2016

Eligibility 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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Leslie A Morrison, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01764451

Organization ID

BVMC 6205

Secondary IDs

U54NS065705

Responsible Party

Principal Investigator

Study Sponsor

University of New Mexico

Collaborators

 National Institute of Neurological Disorders and Stroke (NINDS)

Study Sponsor

Leslie A Morrison, MD, Principal Investigator, University of New Mexico


Verification Date

April 2016