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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HyperQ Signal recording | Device |
| Measure | Description | Time Frame |
|---|---|---|
| HyperQ Signal recorded during the DES Test |
| Measure | Description | Time Frame |
|---|---|---|
| DES Outcome/ Angiography |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David Rosenman, MD | Contact | +972-50-8685923 | ||
| Nechi Almogy, MD | Contact | +972-54-6602697 | nechi@bsp.co.il |
| Name | Affiliation | Role |
|---|---|---|
| David Rosenmann, MD | Shaarey Zedek Hospital, Jerusalem, Israel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiology Department, Shaarey Zedek Hospital | Recruiting | Jerusalem | Israel |
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| Label | URL |
|---|---|
| Biological Signal Processing Ltd. | View source |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 8, 2010 | |
| Reset | Mar 3, 2010 | |
| Release | Mar 28, 2012 | |
| Reset | Apr 18, 2012 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 8, 2010 | Mar 3, 2010 | |||
| Mar 28, 2012 |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D007511 | Ischemia |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D010335 | Pathologic Processes |
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| Apr 18, 2012 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |