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

NCT01325467 | Unknown

• 1 other identifier: Clin_05_01
• Study Type: observational
• Target: 900
• Locations: 1 country
• Sites: 3

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).

Conditions

Coronary Artery Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• years or older
• Referred for exercise MPI due to suspected coronary artery disease

You may not qualify if:

• 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

Sponsors & Collaborators

• BSP Biological Signal Processing Ltd.: lead

Study Sites (3)

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, 55407, United States

RECRUITING

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

RECRUITING

University of Virginia

Charlottesville, Virginia, 22908, United States

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease; Ischemia

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jamieson M Bourque, MD

  University of Virginia Health System

  PRINCIPAL INVESTIGATOR

• Robert Schwartz, MD

  Minneapolis Heart Institute Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2011
• First Posted: March 29, 2011
• Study Start: May 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: March 29, 2012

Record last verified: 2012-03

Locations

US (3)