Trial record 2 of 4 for:
Cerebral Cavernous Malformation
Permeability MRI in Cerebral Cavernous Malformations Type 1 in New Mexico: Effects of Statins
This study is currently recruiting participants.
Verified January 2013 by University of New Mexico
Sponsor:
University of New Mexico
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
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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:
Genetics Home Reference related topics:
capillary malformation-arteriovenous malformation syndrome
cerebral cavernous malformation
Parkes Weber syndrome
Drug Information available for:
Simvastatin
U.S. FDA Resources
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
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 Hemangioma, Cavernous Hemangioma, Cavernous, Central Nervous System Central Nervous System Vascular Malformations Nervous System Malformations Vascular Malformations Cardiovascular Abnormalities Hemangioma Neoplasms, Vascular Tissue Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases |
Hemorrhagic Disorders Hematologic Diseases Nervous System Diseases Simvastatin Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Lipid Regulating Agents Therapeutic Uses Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 21, 2013