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NCT01325467 Clinical Trial

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

Coronary Artery Disease Clinical Trial

— HyperQ  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01325467
Other study ID # Clin_05_01
Secondary ID
Status Recruiting
Phase N/A
First received March 28, 2011
Last updated March 28, 2012
Start date May 2011
Est. completion date May 2012

Study information
Verified date March 2012
Source BSP Biological Signal Processing Ltd.
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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).

Recruitment information / eligibility
Status Recruiting
Enrollment 900
Est. completion date May 2012
Est. primary completion date May 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States University of Virginia Charlottesville Virginia
United States Cleveland Clinic Foundation Cleveland Ohio
United States Minneapolis Heart Institute Foundation Minneapolis Minnesota

Sponsors (1)
Lead Sponsor Collaborator
BSP Biological Signal Processing Ltd.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary CAD status 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 No
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