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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01325467

Acronym

HyperQ

Enrollment

900

Registered

2011-03-29

Start date

2011-05-31

Completion date

2012-05-31

Last updated

2012-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

coronary artery disease, high frequency QRS analysis, ischemia, exercise testing, diagnosis of coronary artery disease

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).

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results