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

March 28, 2012 updated by: BSP Biological Signal Processing Ltd.
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).

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

900

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic Foundation
        • Contact:
          • Ritamarie F. Anselmo, BSN, RN
          • Phone Number: 216-444-9229
          • Email: ANSELMR@CCF.org
        • Contact:
        • Principal Investigator:
          • Balaji Tamarappoo, MD, PhD
        • Sub-Investigator:
          • James D. Thomas, MD, FACC
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Recruiting
        • University of Virginia
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jamieson Bourque, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Consecutive patients referred for an exercise ECG treadmill test with nuclear myocardial perfusion imaging (MPI).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CAD status
Time Frame: one month follow up
The main goal of this registry will be to compare sensitivity, specificity, positive and negative predictive values of the HyperQ HFQRS analysis for detecting the presence of coronary artery disease to that of standard ECG analysis.
one month follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BSP Biological Signal Processing Ltd.

Investigators

  • Principal Investigator: Jamieson M Bourque, MD, University Of Virginia Health System
  • Principal Investigator: Robert Schwartz, MD, Minneapolis Heart Institute Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (ANTICIPATED)

May 1, 2012

Study Completion (ANTICIPATED)

May 1, 2012

Study Registration Dates

First Submitted

March 28, 2011

First Submitted That Met QC Criteria

March 28, 2011

First Posted (ESTIMATE)

March 29, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

March 29, 2012

Last Update Submitted That Met QC Criteria

March 28, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Clin_05_01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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