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

NCT01764451 | Terminated Early Phase 1

• 2 other identifiers: BVMC 6205U54NS065705
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Hispanic

Outcome Measures

Primary Outcomes (1)

• 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).

  Baseline, Three Months

Secondary Outcomes (1)

• Correlation of physiologic permeability data with anatomic lesion data

  Baseline, Three months

Study Arms (2)

Simvastatin

EXPERIMENTAL

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

Drug: Simvastatin

No Treatment

NO INTERVENTION

Interventions

Simvastatin DRUG

Also known as: Zocor

Simvastatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of New Mexico: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator
• University of California, San Francisco: collaborator

Study Sites (1)

University of New Mexico Health Sciences Center

Albuquerque, New Mexico, 87131, United States

Location

Related Links

• Angioma Alliance is an organization by and for those affected by cavernous angiomas and their loved ones, health professionals, and researchers.

MeSH Terms

Conditions

Hemangioma, Cavernous, Central Nervous System

Interventions

Simvastatin

Condition Hierarchy (Ancestors)

Hemangioma, Cavernous; Hemangioma; Neoplasms, Vascular Tissue; Neoplasms by Histologic Type; Neoplasms; Cavernous Sinus Syndromes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Central Nervous System Vascular Malformations; Nervous System Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Hemostatic Disorders; Vascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Leslie A Morrison, MD

  University of New Mexico

  PRINCIPAL INVESTIGATOR

• Blaine Hart, MD

  University of New Mexico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chancellor for Academic Affairs

Study Record Dates

• First Submitted: January 7, 2013
• First Posted: January 9, 2013
• Study Start: March 1, 2012
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: March 12, 2024

Record last verified: 2024-03

Locations

US (1)