Frequency Analysis of Coronary Artery Disease | NCT01043237

Studies
Frequency Analysis of Coronary Artery Disease

NCT01043237

Sponsor

University of Minnesota

Status

Completed

Last Update Posted

Sep 5, 2014Estimated

Enrollment

330Actual

Phase

Not provided

Conditions

Coronary 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

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2009

Primary Completion Date

Mar 2013Actual

Completion Date

Mar 2013Actual

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 3, 2014

Last Update Posted Date

Sep 5, 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 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.

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

330Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

89 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Robert Wilson, MD	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
D003324	Coronary Artery Disease
D004194	Disease

Ancestor Terms

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided