TerminatedEarly Phase 1

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

Stopped: 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.

United States12 participantsStarted 2012-03

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in blood brain barrier permeability over three months for the treatment group compared to the control group.

Timeframe: Baseline, Three Months

Trial details

NCT IDNCT01764451

SponsorUniversity of New Mexico

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-01

View on ClinicalTrials.gov More Cavernous Angioma, Familial trials