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

• Conditions: Coronary Artery Disease

• Registration Number: NCT01325467
• Lead Sponsor: BSP Biological Signal Processing Ltd.

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2011-03-28
• Study First Submitted QC: 2011-03-28
• Study First Posted: 2011-03-29
• Study Start: 2011-05
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-28
• Last Update Posted: 2012-03-29
• Primary Completion: 2012-05
• Study Completion: 2012-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 900

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
CAD status	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.

Trial Locations

Locations (3)

Minneapolis Heart Institute Foundation; 🇺🇸 Minneapolis, Minnesota, United States

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States