NCT01042912

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2009

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 4, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 6, 2010

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

September 19, 2014

Status Verified

September 1, 2014

Enrollment Period

9 months

First QC Date

January 4, 2010

Last Update Submit

September 18, 2014

Conditions

Carotid Artery Disease

Keywords

diagnosiscarotidarterydiseaseauscultationsound

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

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

You may not qualify if:

  • Pregnant women
  • Prior carotid intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota Medical Center (UMMC) Fairview Clinics

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Carotid Artery DiseasesDisease

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Marie A Johnson, PhD

    University of Minnesota

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2010

First Posted

January 6, 2010

Study Start

May 1, 2009

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

September 19, 2014

Record last verified: 2014-09

Locations

US(1)