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| Sponsored by: |
BSP Biological Signal Processing Ltd. |
|---|---|
| Information provided by: | BSP Biological Signal Processing Ltd. |
| ClinicalTrials.gov Identifier: | NCT00310622 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Myocardial Ischemia |
Device: HyperQ Signal recording |
Phase III |
| Study Type: | Interventional |
| Study Design: | Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
| Official Title: | An Assessment of the HyperQ Signal for Detecting Ischemia During Dobutamine Stress Echocardiography (DSE) |
| Estimated Enrollment: | 150 |
| Study Start Date: | March 2006 |
| Estimated Study Completion Date: | February 2007 |
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: David Rosenman, MD | +972-50-8685923 | |
| Contact: Nechi Almogy, MD | +972-54-6602697 | nechi@bsp.co.il |
| Israel | |
| Cardiology Department, Shaarey Zedek Hospital | Recruiting |
| Jerusalem, Israel | |
| Principal Investigator: | David Rosenmann, MD | Shaarey Zedek Hospital, Jerusalem, Israel |
More Information
| Study ID Numbers: | SHZ01 |
| Study First Received: | April 2, 2006 |
| Last Updated: | February 28, 2007 |
| ClinicalTrials.gov Identifier: | NCT00310622 |
| Health Authority: | Israel: Ethics Commission |
|
HyperQ Ischemia dobutamine |
|
Heart Diseases Myocardial Ischemia Vascular Diseases |
Stress Ischemia Dobutamine |
|
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic beta-Agonists Adrenergic Agents Cardiotonic Agents Sympathomimetics Physiological Effects of Drugs Cardiovascular Agents |
Protective Agents Pharmacologic Actions Adrenergic Agonists Pathologic Processes Autonomic Agents Therapeutic Uses Cardiovascular Diseases Peripheral Nervous System Agents |
