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

Primary Purpose

Cavernous Angioma, Familial, Cerebral Cavernous Malformations, Cerebral Cavernous Hemangioma

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Simvastatin
Sponsored by
University of New Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cavernous Angioma, Familial focused on measuring Hispanic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of New Mexico Health Sciences Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Simvastatin

No Treatment

Arm Description

20-40 mg tablet taken daily by mouth. Month 1: 20 mg; Months 2 and 3: 40 mg.

Outcomes

Primary Outcome Measures

Change in blood brain barrier permeability over three months for the treatment group compared to the control group.
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
Use dynamic contrast-enhanced MRI to detect abnormalities in brain permeability in CCM patients and correlate with anatomic lesion information.

Full Information

First Posted
January 7, 2013
Last Updated
April 7, 2016
Sponsor
University of New Mexico
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS), University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT01764451
Brief Title
Permeability MRI in Cerebral Cavernous Malformations Type 1 in New Mexico: Effects of Statins
Official Title
Permeability MRI in Cerebral Cavernous Malformations Type 1 in New Mexico: Effects of Statins
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of New Mexico
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS), University of California, San Francisco

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cavernous Angioma, Familial, Cerebral Cavernous Malformations, Cerebral Cavernous Hemangioma
Keywords
Hispanic

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Simvastatin
Arm Type
Experimental
Arm Description
20-40 mg tablet taken daily by mouth. Month 1: 20 mg; Months 2 and 3: 40 mg.
Arm Title
No Treatment
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Simvastatin
Other Intervention Name(s)
Zocor
Primary Outcome Measure Information:
Title
Change in blood brain barrier permeability over three months for the treatment group compared to the control group.
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).
Time Frame
Baseline, Three Months
Secondary Outcome Measure Information:
Title
Correlation of physiologic permeability data with anatomic lesion data
Description
Use dynamic contrast-enhanced MRI to detect abnormalities in brain permeability in CCM patients and correlate with anatomic lesion information.
Time Frame
Baseline, Three months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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. 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leslie A Morrison, MD
Organizational Affiliation
University of New Mexico
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Blaine Hart, MD
Organizational Affiliation
University of New Mexico
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of New Mexico Health Sciences Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.angiomaalliance.org/
Description
Angioma Alliance is an organization by and for those affected by cavernous angiomas and their loved ones, health professionals, and researchers.

Learn more about this trial

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

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