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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by University of New Mexico
Sponsor:
Collaborators:
University of California, San Francisco
Information provided by (Responsible Party):
Leslie Morrison, University of New Mexico
ClinicalTrials.gov Identifier:
NCT01764451
First received: January 7, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Cavernous Angioma, Familial
Cerebral Cavernous Malformations
Cerebral Cavernous Hemangioma
Drug: Simvastatin
Phase 0

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of New Mexico:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 30
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)
Arms Assigned Interventions
Experimental: Simvastatin
20-40 mg tablet taken daily by mouth. Month 1: 20 mg; Months 2 and 3: 40 mg.
Drug: Simvastatin
Other Name: Zocor
No Intervention: No Treatment

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01764451

Contacts
Contact: Beth A Baca, MSW 505-272-3194 babaca@salud.unm.edu

Locations
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    babaca@salud.unm.edu   
Principal Investigator: Leslie A Morrison, MD         
Sub-Investigator: Blaine Hart, MD         
Sponsors and Collaborators
University of New Mexico
University of California, San Francisco
Investigators
Principal Investigator: Leslie A Morrison, MD University of New Mexico
Principal Investigator: Blaine Hart, MD University of New Mexico
  More Information

Additional Information:
No publications provided

Responsible Party: Leslie Morrison, Vice Chancellor for Academic Affairs, University of New Mexico
ClinicalTrials.gov Identifier: NCT01764451     History of Changes
Other Study ID Numbers: BVMC 6205, U54NS065705
Study First Received: January 7, 2013
Last Updated: January 7, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of New Mexico:
Hispanic

Additional relevant MeSH terms:
Congenital Abnormalities
Central Nervous System Vascular Malformations
Nervous System Malformations
Vascular Malformations
Cardiovascular Abnormalities
Hemangioma
Hemangioma, Cavernous
Hemangioma, Cavernous, Central Nervous System
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
Hematologic Diseases
Nervous System Diseases
Simvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 16, 2014