Clinical trial NCT01764451: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Cavernous Angioma, Familial
Cerebral Cavernous Malformations
Cerebral Cavernous Hemangioma
Keywords: Hispanic
Lead sponsor: University of New Mexico
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
name: University of California, San Francisco
First posted: 2013-01-09
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in blood brain barrier permeability over three months for the treatment group compared to the control group.
timeFrame: Baseline, Three Months
Secondary outcomes:
measure: Correlation of physiologic permeability data with anatomic lesion data
timeFrame: Baseline, Three months
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico Health Sciences Center
state: New Mexico
Study officials:
affiliation: University of New Mexico
name: Leslie A Morrison, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of New Mexico
name: Blaine Hart, MD
role: PRINCIPAL_INVESTIGATOR
References: