Recruiting

Coronary Artery Disease

Sponsor:

BSP Biological Signal Processing Ltd.

Code:

NCT01325467

Conditions

Coronary Artery Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT01325467

Start date

May, 2011

Status verified date

Mar, 2012

Completion date

May, 2012

Anticipated

Primary completion date

May, 2012

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

900 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • CAD status [ Time Frame: one month follow up ]

Central Contacts and Locations

Locations

Minneapolis Heart Institute Foundation

Recruiting

Minneapolis, Minnesota, United States, 55407

Contacts

Jo Anne Goldman, RT, RCIS, CCRC

612-863-3793JoAnne.Goldman@allina.com

Rob Schwartz, MD

612-863-3823robert.Schwartz@allina.com

Principal Investigator:

Robert Schwartz, MD

Cleveland Clinic Foundation

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Ritamarie F. Anselmo, BSN, RN

216-444-9229ANSELMR@CCF.org

Cindy Stevenson, RN

216-444-9417stevenc@CCF.org

Principal Investigator:

Balaji Tamarappoo, MD, PhD

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

Jamie Bourque, MD

434-982-4661jbourque@virginia.edu

Jayne Missel, RN BSN CCRC

434-243-7195JSM3S@hscmail.mcc.virginia.edu

Principal Investigator:

Jamieson Bourque, MD

More Information

Sponsor

BSP Biological Signal Processing Ltd.

Last update posted

Mar 29, 2012

Last verified

Mar, 2012

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by BSP Biological Signal Processing Ltd. on 2012-03-29.