NCT01043237

Brief Summary

The purpose of this study is to determine if coronary artery disease can be detected using an electronic, acoustic recording instrument. The presence or absence of abnormal pathology will be confirmed by diagnostic angiography as part of the normal patient care at this institution.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
330

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

March 1, 2009

Completed
10 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
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

September 5, 2014

Status Verified

September 1, 2014

Enrollment Period

4 years

First QC Date

January 4, 2010

Last Update Submit

September 3, 2014

Conditions

Coronary Artery Disease

Keywords

acousticdigitalsoundvibrationcoronaryauscultationarterydiagnosis

Outcome Measures

Primary Outcomes (1)

  • to determine if coronary artery disease can be detected using an electronic, acoustic recording instrument

    to determine if coronary artery disease can be detected using an electronic, acoustic recording instrument

    Baselin

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients presenting to the University of Minnesota Medical Center (UMMC) Fairview Clinics, Physicians (UMP) or the Redwing, Minnesota clinic

You may qualify if:

  • Patients aged 18-89 years old and recommended for a cardiology related angiogram within 24 hours

You may not qualify if:

  • Any patient less than 18 years of age or greater than 89 years of age.
  • Any patient with any of the following conditions: pregnant or nursing, prior myocardial infarction, left ventricular device, heart transplant, valve replacement, congestive heart failure, atrial fibrillation (non-intermittent), endocarditis or any heart viral or bacterial infection, any patient who has or requires medication or other heart rhythm altering treatment.

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

Coronary Artery DiseaseDisease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Robert Wilson, MD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

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

March 1, 2009

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

September 5, 2014

Record last verified: 2014-09

Locations

US(1)