Myocardial IschemiaPhase 3NCT00310622
Assessment of HyperQ Signal for Detecting Ischemia During Dobutamine Stress ECG
A Phase 3 study testing HyperQ Signal recording in people with Myocardial Ischemia, run by BSP Biological Signal Processing Ltd. at 1 site in Israel.
Trial summary
The purpose of the study is to verify the ability of the HyperQ signal to detect Dobutamine induced Ischemia. The gold standard for ischemia will be the results of Angiography if performed, or Echocardiographic imaging, which was performed during the test. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Myocardial Ischemia
- What is being tested?
- HyperQ Signal recording
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2006to Feb 2007
- Phase
- Phase 3
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subject referred to dobutamine stress Echocardiography
- Subject signed informed consent
Who cannot join
- Subjects with implantable Pacemakers or Defibrillators
- Subjects with Wolff-Parkinson-White Syndrome
Trial locations and contacts
1 site in 1 country.
David Rosenman, MD contact
Israel1 site, 1 recruiting
- Recruiting
Cardiology Department, Shaarey Zedek Hospital
Jerusalem
About this study
Official title: An Assessment of the HyperQ Signal for Detecting Ischemia During Dobutamine Stress Echocardiography (DSE)
The purpose of the study is to verify the ability of the HyperQ signal to detect Dobutamine induced Ischemia. The gold standard for ischemia will be the results of Angiography if performed, or Echocardiographic imaging, which was performed during the test.
Read the detailed description
Subjects referred for Dobutamine Stress Echocardiography who will sign an Informed consent form will go through the test. High resolution ECG from 12 leads will be recorded using BSP's HyperQ system before, during and following the Echo testing. This wil be done without interfering or affecting any aspect of the normal procedure. Standard Protocol will be used with standard test termination indications.
The Diagnostic stage will include analysis of the hyperQ signal, aiming to classify results as ischemic or non-ischemic.
The HyperQ data will be compared to DSE results which will be used as the "gold standard" for this study unless Angiography results are obtained.
An additional comparison evaluation will be performed to assess the advantage of the HyperQ results on the ST-changes results obtained from conventional ECG.In addition all recruited subjects will be followed for up to 12 months.During this period a phone call will be performed every 3 months to evaluate cardiac status, hospitalization and especially Angiography procedures.
- Conditions
- Myocardial Ischemia
- Being tested
- HyperQ Signal recording
- Keywords
- HyperQ, Ischemia, dobutamine
- Medical subject headings
- Myocardial Ischemia, Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HyperQ Signal recordingDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
HyperQ Signal recorded during the DES Test
Secondary outcomes (1)
DES Outcome/ Angiography
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2006 (estimated)
- Study startMar 2006
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial IschemiaStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants
Sponsor and investigators
- Lead sponsor
- BSP Biological Signal Processing Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- David Rosenmann, MD, Principal investigator, Shaarey Zedek Hospital, Jerusalem, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00310622
- Sponsor's protocol ID
- SHZ01
- Status last verified
- Feb 2007
- First submitted
- 2 Apr 2006
- Last updated
- 1 Mar 2007
- Results posted
- No