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
Information provided by (Responsible Party):
BSP Biological Signal Processing Ltd.
First received: March 28, 2011
Last updated: March 28, 2012
Last verified: March 2012
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).
||Observational Model: Case-Only
Time Perspective: Prospective
||Detection of Coronary Artery Disease Using Analysis of High Frequency QRS: The HyperQ Registry
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:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||May 2012 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Consecutive patients referred for an exercise ECG treadmill test with nuclear myocardial perfusion imaging (MPI).
- 18 years or older
- Referred for exercise MPI due to suspected coronary artery disease
- 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
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
|Minneapolis Heart Institute Foundation
|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 |
|Cleveland Clinic Foundation
|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 |
|University of Virginia
|Charlottesville, Virginia, United States, 22908 |
|Contact: Jamie Bourque, MD 434-982-4661 email@example.com |
|Contact: Jayne Missel, RN BSN CCRC 434-243-7195 JSM3S@hscmail.mcc.virginia.edu |
|Principal Investigator: Jamieson Bourque, MD |
BSP Biological Signal Processing Ltd.
||Jamieson M Bourque, MD
||University of Virginia Health System
||Robert Schwartz, MD
||Minneapolis Heart Institute Foundation
No publications provided
||BSP Biological Signal Processing Ltd.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||March 28, 2011
||March 28, 2012
||United States: Institutional Review Board
Keywords provided by BSP Biological Signal Processing Ltd.:
coronary artery disease
high frequency QRS analysis
diagnosis of coronary artery disease
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on November 20, 2014
Coronary Artery Disease
Arterial Occlusive Diseases