Assessment of HyperQ Signal for Detecting Ischemia During Dobutamine Stress ECG
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|ClinicalTrials.gov Identifier: NCT00310622|
Recruitment Status : Unknown
Verified February 2007 by BSP Biological Signal Processing Ltd..
Recruitment status was: Recruiting
First Posted : April 4, 2006
Last Update Posted : March 1, 2007
|Condition or disease||Intervention/treatment||Phase|
|Myocardial Ischemia||Device: HyperQ Signal recording||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||150 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Assessment of the HyperQ Signal for Detecting Ischemia During Dobutamine Stress Echocardiography (DSE)|
|Study Start Date :||March 2006|
|Study Completion Date :||February 2007|
- HyperQ Signal recorded during the DES Test
- DES Outcome/ Angiography
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00310622
|Contact: David Rosenman, MD||+972-50-8685923|
|Contact: Nechi Almogy, MDfirstname.lastname@example.org|
|Cardiology Department, Shaarey Zedek Hospital||Recruiting|
|Principal Investigator:||David Rosenmann, MD||Shaarey Zedek Hospital, Jerusalem, Israel|