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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by BSP Biological Signal Processing Ltd..
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
BSP Biological Signal Processing Ltd.
ClinicalTrials.gov Identifier:
NCT01325467
First received: March 28, 2011
Last updated: March 28, 2012
Last verified: March 2012
  Purpose

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).


Condition
Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Detection of Coronary Artery Disease Using Analysis of High Frequency QRS: The HyperQ Registry

Further study details as provided by BSP Biological Signal Processing Ltd.:

Primary Outcome Measures:
  • CAD status [ Time Frame: one month follow up ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 900
Study Start Date: May 2011
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01325467

Locations
United States, Minnesota
Minneapolis Heart Institute Foundation Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Jo Anne Goldman, RT, RCIS, CCRC    612-863-3793    JoAnne.Goldman@allina.com   
Contact: Rob Schwartz, MD    612-863-3823    robert.Schwartz@allina.com   
Principal Investigator: Robert Schwartz, MD         
United States, Ohio
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Ritamarie F. Anselmo, BSN, RN    216-444-9229    ANSELMR@CCF.org   
Contact: Cindy Stevenson, RN    216-444-9417    stevenc@CCF.org   
Principal Investigator: Balaji Tamarappoo, MD, PhD         
Sub-Investigator: James D. Thomas, MD, FACC         
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Jamie Bourque, MD    434-982-4661    jbourque@virginia.edu   
Contact: Jayne Missel, RN BSN CCRC    434-243-7195    JSM3S@hscmail.mcc.virginia.edu   
Principal Investigator: Jamieson Bourque, MD         
Sponsors and Collaborators
BSP Biological Signal Processing Ltd.
Investigators
Principal Investigator: Jamieson M Bourque, MD University of Virginia Health System
Principal Investigator: Robert Schwartz, MD Minneapolis Heart Institute Foundation
  More Information

No publications provided

Responsible Party: BSP Biological Signal Processing Ltd.
ClinicalTrials.gov Identifier: NCT01325467     History of Changes
Other Study ID Numbers: Clin_05_01
Study First Received: March 28, 2011
Last Updated: March 28, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by BSP Biological Signal Processing Ltd.:
coronary artery disease
high frequency QRS analysis
ischemia
exercise testing
diagnosis of coronary artery disease

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014