Detection of Coronary Artery Disease Using Analysis of High Frequency QRS: The HyperQ Registry

NCT ID: NCT01325467

Last Updated: 2012-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

900 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-05-31

Study Completion Date

2012-05-31

Brief Summary

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This will be a registry study that will enroll patients referred for an ECG treadmill test with nuclear myocardial perfusion imaging (MPI). The high frequency QRS (HFQRS) information will be recorded and analyzed automatically and simultaneous with the standard ECG signals by the HyperQ System. Results of subsequent tests performed on each patient will be collected and used to enhance the reliability of designating each patient as a CAD-negative (i.e., no significant coronary artery disease) or a CAD-positive (i.e., significant coronary artery disease).

Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* 18 years or older
* Referred for exercise MPI due to suspected coronary artery disease

Exclusion Criteria

* Acute Coronary Syndrome (Unstable angina/NSTEMI/STEMI)
* Pre-excitation syndrome
* QRS duration \> 120 ms
* Atrial Fibrillation or significant ventricular arrhythmia
* Treatment with Digoxin
* Pacemaker with 100% pacemaker dependence
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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BSP Biological Signal Processing Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jamieson M Bourque, MD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia Health System

Robert Schwartz, MD

Role: PRINCIPAL_INVESTIGATOR

Minneapolis Heart Institute Foundation

Locations

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Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, United States

Site Status RECRUITING

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status RECRUITING

University of Virginia

Charlottesville, Virginia, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Jo Anne Goldman, RT, RCIS, CCRC

Role: primary

612-863-3793

Rob Schwartz, MD

Role: backup

612-863-3823

Ritamarie F. Anselmo, BSN, RN

Role: primary

216-444-9229

Cindy Stevenson, RN

Role: backup

216-444-9417

Jamie Bourque, MD

Role: primary

434-982-4661

Jayne Missel, RN BSN CCRC

Role: backup

434-243-7195

Other Identifiers

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Clin_05_01

Identifier Type: -

Identifier Source: org_study_id

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