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

Phase 0
18 Years
Open (Enrolling)
Cavernous Angioma, Familial, Cerebral Cavernous Malformations, Cerebral Cavernous Hemangioma

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Trial Information

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

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.

- Indication for statin treatment based on the National Cholesterol Education Program
(NCEP) ATPIII Guidelines:

- LDL greater than or equal to 160.

- LDL of 130-159 AND two or more risk factors (e.g., cigarette smoking, hypertension,
low HDL cholesterol) AND 10-year coronary heart disease (CHD) risk or 10-20%.

- LDL of 101-159 AND coronary heart disease, diabetes mellitus, symptomatic carotic
artery disease, peripheral arterial disease, or abdominal aortic aneurysm OR 10-year
CHD equivalent risk > 20%.

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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Change in blood brain barrier permeability over three months for the treatment group compared to the control group.

Outcome Description:

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).

Outcome Time Frame:

Baseline, Three Months

Safety Issue:


Principal Investigator

Leslie A Morrison, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of New Mexico


United States: Institutional Review Board

Study ID:

BVMC 6205



Start Date:

March 2012

Completion Date:

June 2013

Related Keywords:

  • Cavernous Angioma, Familial
  • Cerebral Cavernous Malformations
  • Cerebral Cavernous Hemangioma
  • Hispanic
  • Congenital Abnormalities
  • Hemangioma
  • Hemangioma, Cavernous
  • Hemangioma, Cavernous, Central Nervous System



University of New Mexico Health Sciences CenterAlbuquerque, New Mexico  87131