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Clinical Trials/NCT01325467
NCT01325467
Unknown
Not Applicable

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

BSP Biological Signal Processing Ltd.3 sites in 1 country900 target enrollmentMay 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Coronary Artery Disease
Sponsor
BSP Biological Signal Processing Ltd.
Enrollment
900
Locations
3
Primary Endpoint
CAD status
Last Updated
14 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
May 2011
End Date
May 2012
Last Updated
14 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
BSP Biological Signal Processing Ltd.
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

Study Sites (3)

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