Clinical trial · Interventional
Permeability MRI in Cerebral Cavernous Malformations Type 1 in New Mexico: Effects of Statins
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Research was completed before January 18, 2017, \& does not meet the Applicable Clinical Trial requirement to register \& report results per the guidance provided in "Clinical Trials Registration \& Results Information Submission" dated 09/21/2016.
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cavernous Angioma, Familial | Cavernous Hemangioma | ALIAS | 0.85 |
| Cerebral Cavernous Hemangioma | — | UNRESOLVED | — |
| Cerebral Cavernous Malformations | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Simvastatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Simvastatin
- description
- 20-40 mg tablet taken daily by mouth. Month 1: 20 mg; Months 2 and 3: 40 mg.
- interventionNames
- Drug: Simvastatin
- type
- NO_INTERVENTION
- label
- No Treatment
Primary outcomes (1)
- measure
- Change in blood brain barrier permeability over three months for the treatment group compared to the control group.
- timeFrame
- Baseline, Three Months
- 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).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available