Permeability MRI in Cerebral Cavernous Malformations Type... | NCT01764451

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

NCT01764451

Sponsor

University of New Mexico

Status

Terminated

Last Update Posted

Mar 12, 2024Actual

Enrollment

12Actual

Phase

Early Phase 1

Conditions

Cavernous Angioma, Familial
Cerebral Cavernous Malformations
Cerebral Cavernous Hemangioma

Interventions

Simvastatin

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
U54NS065705	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Mar 2024

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why 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.

Expanded Access Info

Start Date

Mar 2012Actual

Primary Completion Date

Jan 2016Actual

Completion Date

Jan 2016Actual

First Submitted Date

Jan 7, 2013

First Submission Date that Met QC Criteria

Jan 7, 2013

First Posted Date

Jan 9, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 8, 2024

Last Update Posted Date

Mar 12, 2024Actual

Name	Class
National Institute of Neurological Disorders and Stroke (NINDS)	NIH
University of California, San Francisco	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Simvastatin	Drug		Simvastatin	Zocor

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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.	Baseline, Three months

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Leslie A Morrison, MD	University of New Mexico	Principal Investigator
Blaine Hart, MD	University of New Mexico	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of New Mexico Health Sciences Center		Albuquerque	New Mexico	87131	United States

References Module

Citations

Not provided

ID	Term
D006392	Hemangioma, Cavernous
D006391	Hemangioma
D009383	Neoplasms, Vascular Tissue
D009370	Neoplasms by Histologic Type

ID	Term
D008148	Lovastatin
D009281	Naphthalenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic