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

Cerebral Cavernous Malformations Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01764451
• Other study ID #: BVMC 6205
• Secondary ID: U54NS065705
• Status: Terminated
• Phase: Early Phase 1
• Start date: March 2012
• Est. completion date: January 2016

Study information

• Verified date: March 2024
• Source: University of New Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cavernous Angioma, Familial
• Cerebral Cavernous Hemangioma
• Cerebral Cavernous Malformations
• Congenital Abnormalities
• Hemangioma

Intervention

Drug:
• Simvastatin

Locations

Country	Name	City	State
United States	University of New Mexico Health Sciences Center	Albuquerque	New Mexico

Sponsors (3)

Lead Sponsor	Collaborator
University of New Mexico	National Institute of Neurological Disorders and Stroke (NINDS), University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in blood brain barrier permeability over three months for the treatment group compared to the control group.	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).	Baseline, Three Months
Secondary	Correlation of physiologic permeability data with anatomic lesion data	Use dynamic contrast-enhanced MRI to detect abnormalities in brain permeability in CCM patients and correlate with anatomic lesion information.	Baseline, Three months

External Links

•   Angioma Alliance is an organization by and for those affected by cavernous angiomas and their loved ones, health professionals, and researchers.