Frequency Analysis of Carotid Artery Disease | NCT01042912

Studies
Frequency Analysis of Carotid Artery Disease

NCT01042912

Sponsor

University of Minnesota

Status

Withdrawn

Last Update Posted

Sep 19, 2014Estimated

Enrollment

0Actual

Phase

Not provided

Conditions

Carotid Artery Disease

Interventions

Not provided

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 2014

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

PI left inistitution

Expanded Access Info

Start Date

May 2009

Primary Completion Date

Feb 2010Estimated

Completion Date

Feb 2010Estimated

First Submitted Date

Jan 4, 2010

First Submission Date that Met QC Criteria

Jan 4, 2010

First Posted Date

Jan 6, 2010Estimated

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 18, 2014

Last Update Posted Date

Sep 19, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The purpose of this study is to determine if carotid artery stenosis can be detected using an electronic stethoscope. This study will use a commercially available electronic stethoscope to record carotid sounds in patients with suspected carotid artery stenosis. The presence of absence of abnormal vessels will be confirmed by diagnostic ultrasound as part of normal patient care at this institution.

Detailed Description

Not provided

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 40-80
Indicated for diagnostic ultrasound related to carotid artery stenosis

Exclusion Criteria:

Pregnant women
Prior carotid intervention

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Any inpatient or outpatient with inclusion criteria met and exclusion criteria not met presenting for aniography to the University of Minnesota Fairview Hospital or Clinic in Minneapolis or Redwing, Minnesota

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marie A Johnson, PhD	University of Minnesota	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Minnesota Medical Center (UMMC) Fairview Clinics		Minneapolis	Minnesota	55455	United States

Condition Browse Module

MeSH Terms

ID	Term
D002340	Carotid Artery Diseases
D004194	Disease

Ancestor Terms

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided