Permeability MRI in Cerebral Cavernous Malformations Type 1 in New Mexico: Effects of Statins
Recruitment status was Recruiting
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.
Cavernous Angioma, Familial
Cerebral Cavernous Malformations
Cerebral Cavernous Hemangioma
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Permeability MRI in Cerebral Cavernous Malformations Type 1 in New Mexico: Effects of Statins|
- Change in blood brain barrier permeability over three months for the treatment group compared to the control group. [ Time Frame: Baseline, Three Months ] [ Designated as safety issue: No ]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).
- Correlation of physiologic permeability data with anatomic lesion data [ Time Frame: Baseline, Three months ] [ Designated as safety issue: No ]Use dynamic contrast-enhanced MRI to detect abnormalities in brain permeability in CCM patients and correlate with anatomic lesion information.
|Study Start Date:||March 2012|
|Estimated Study Completion Date:||June 2013|
|Estimated Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
20-40 mg tablet taken daily by mouth. Month 1: 20 mg; Months 2 and 3: 40 mg.
Other Name: Zocor
|No Intervention: No Treatment|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01764451
|Contact: Beth A Baca, MSWemail@example.com|
|United States, New Mexico|
|University of New Mexico Health Sciences Center||Recruiting|
|Albuquerque, New Mexico, United States, 87131|
|Contact: Beth Baca, MSW 505-272-3194 firstname.lastname@example.org|
|Principal Investigator: Leslie A Morrison, MD|
|Sub-Investigator: Blaine Hart, MD|
|Principal Investigator:||Leslie A Morrison, MD||University of New Mexico|
|Principal Investigator:||Blaine Hart, MD||University of New Mexico|