Permeability MRI in Cerebral Cavernous Malformations Type 1 in New Mexico: Effects of Statins
| Status: | Completed |
|---|---|
| Conditions: | Women's Studies, Hematology |
| Therapuetic Areas: | Hematology, Reproductive |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | March 2012 |
| End Date: | January 2016 |
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.
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.
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
We found this trial at
1
site
Click here to add this to my saved trials
