Coronary Artery DiseaseHyperQNCT01325467
Detection of Coronary Artery Disease Using Analysis of High Frequency QRS: The HyperQ Registry
An observational study of Coronary Artery Disease, run by BSP Biological Signal Processing Ltd. at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 900 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2011to May 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients referred for an exercise ECG treadmill test with nuclear myocardial perfusion imaging (MPI).
Who may be able to join
- 18 years or older
- Referred for exercise MPI due to suspected coronary artery disease
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites, 3 recruiting
- Recruiting
University of Virginia
Charlottesville, Virginia, 22908
Jamie Bourque, MD, 434-982-4661, jbourque@virginia.edu
Jayne Missel, RN BSN CCRC, 434-243-7195, JSM3S@hscmail.mcc.virginia.edu
- Recruiting
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Ritamarie F. Anselmo, BSN, RN, 216-444-9229, ANSELMR@CCF.org
Cindy Stevenson, RN, 216-444-9417, stevenc@CCF.org
- Recruiting
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407
Jo Anne Goldman, RT, RCIS, CCRC, 612-863-3793, JoAnne.Goldman@allina.com
Rob Schwartz, MD, 612-863-3823, robert.Schwartz@allina.com
About this study
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
- Medical subject headings
- Coronary Artery Disease, Ischemia
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2011 (estimated)
- Study startMay 2011
- Primary completionMay 2012 (estimated)
- Study completionMay 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BSP Biological Signal Processing Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jamieson M Bourque, MD, Principal investigator, University of Virginia Health SystemRobert Schwartz, MD, Principal investigator, Minneapolis Heart Institute Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01325467
- Sponsor's protocol ID
- Clin_05_01
- Acronym
- HyperQ
- Status last verified
- Mar 2012
- First submitted
- 28 Mar 2011
- Last updated
- 29 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Coronary Artery Disease Using Analysis of High Frequency QRS: The HyperQ Registry
- ClinicalTrials.gov ID
- NCT01325467
- Acronym / sponsor ID
- HyperQ / Clin_05_01
- Conditions
- Coronary Artery Disease
- Keywords
- coronary artery disease, high frequency QRS analysis, ischemia, exercise testing, diagnosis of coronary artery disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- BSP Biological Signal Processing Ltd.Industry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- May 2012 (estimated)
- Study completion
- May 2012 (estimated)
- First posted
- 29 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients referred for an exercise ECG treadmill test with nuclear myocardial perfusion imaging (MPI).
Key inclusion criteria (2 listed)
- 18 years or older
- Referred for exercise MPI due to suspected coronary artery disease
Key exclusion criteria (6 listed)
- Acute Coronary Syndrome (Unstable angina/NSTEMI/STEMI)
- Pre-excitation syndrome
- QRS duration > 120 ms
- Atrial Fibrillation or significant ventricular arrhythmia
- Treatment with Digoxin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
CAD status
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Minneapolis Heart Institute Foundation
Minneapolis, United States
Jamieson M Bourque, MD principal investigator
University of Virginia Health System
Robert Schwartz, MD principal investigator
Minneapolis Heart Institute Foundation
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by BSP Biological Signal Processing Ltd. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CAD status (time frame: one month follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2012.