Use of in Vivo 3T MR to Characterize Carotid Plaque in Pa... | NCT02335567

Studies
Use of in Vivo 3T MR to Characterize Carotid Plaque in Patients and Correlate MR Findings With Symptoms

NCT02335567

Sponsor

Michigan State University

Status

Completed

Last Update Posted

Sep 16, 2016Estimated

Enrollment

162Actual

Phase

Not provided

Conditions

Carotid Plaque Hemorrhage Appearance

Interventions

there is no intervention

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

Status Module

Record Verification Date

Sep 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2012

Primary Completion Date

Jan 2016Actual

Completion Date

Jan 2016Actual

First Submitted Date

Jan 7, 2015

First Submission Date that Met QC Criteria

Jan 8, 2015

First Posted Date

Jan 9, 2015Estimated

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

Sep 15, 2016

Last Update Posted Date

Sep 16, 2016Estimated

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

To compare two competing newly designed 3D sequences for black blood carotid plaque imaging techniques with the industry standard 2D sequnce for black blood.

Detailed Description

To utilize a 3D sequence instead of the usual 2D commonly standard industry sequence that is supplied by the various manufacturers.

Patients with greater than 50% stenosis that are 3T compatible are imaged using the two sequences to compare which sequences better visualize the plaque and it's characteristics

The purpose is to validate the ability of the new 3D sequence to detect and measure any plaque hemorrhage as well as to identify region sof Type 1 hemorrhage.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

162Actual

Name	Type	Description	Arm Group Labels	Other Names
there is no intervention	Other

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Appearance of intraplaque hemorrhage	what radiologist interperts	1 day of scan

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with 50% stenosis of the carotid arteries that are safe to undergo MRI imaging

Exclusion Criteria:

Patients that are determined to no be safe to undergo MR imaging due to implants

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with 50% asymptomatic stenosis of the carotid artery that are safe to undergo 3 tesla MRI imaging.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Michigan State University - Department of Radiology		East Lansing	Michigan	48824	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23194832	Background	Ota H, Reeves MJ, Zhu DC, Majid A, Collar A, Yuan C, DeMarco JK. Sex differences of high-risk carotid atherosclerotic plaque with less than 50% stenosis in asymptomatic patients: an in vivo 3T MRI study. AJNR Am J Neuroradiol. 2013 May;34(5):1049-55, S1. doi: 10.3174/ajnr.A3399. Epub 2012 Nov 29.
22548930	Background