Permeability MRI in Cerebral Cavernous Malformations Type 1 in New Mexico: Effects of Statins
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01764451|
Recruitment Status : Completed
First Posted : January 9, 2013
Last Update Posted : April 11, 2016
|Condition or disease||Intervention/treatment||Phase|
|Cavernous Angioma, Familial Cerebral Cavernous Malformations Cerebral Cavernous Hemangioma||Drug: Simvastatin||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Permeability MRI in Cerebral Cavernous Malformations Type 1 in New Mexico: Effects of Statins|
|Study Start Date :||March 2012|
|Primary Completion Date :||January 2016|
|Study Completion Date :||January 2016|
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|
- Change in blood brain barrier permeability over three months for the treatment group compared to the control group. [ Time Frame: Baseline, Three Months ]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 ]Use dynamic contrast-enhanced MRI to detect abnormalities in brain permeability in CCM patients and correlate with anatomic lesion information.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01764451
|United States, New Mexico|
|University of New Mexico Health Sciences Center|
|Albuquerque, New Mexico, United States, 87131|
|Principal Investigator:||Leslie A Morrison, MD||University of New Mexico|
|Principal Investigator:||Blaine Hart, MD||University of New Mexico|