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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

EARLY_PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2016-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Cavernous Angioma, Familial Cerebral Cavernous Malformations Cerebral Cavernous Hemangioma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Simvastatin

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

Group Type EXPERIMENTAL

Simvastatin

Intervention Type DRUG

No Treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Simvastatin

Intervention Type DRUG

Other Intervention Names

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Zocor

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No