Assessment of HyperQ Signal for Detecting Ischemia During Dobutamine Stress ECG

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by:
BSP Biological Signal Processing Ltd.

Brief 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.

Condition or disease Intervention/treatment Phase
Myocardial Ischemia Device: HyperQ Signal recording Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. HyperQ Signal recorded during the DES Test

Secondary Outcome Measures :
  1. DES Outcome/ Angiography

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subject referred to dobutamine stress Echocardiography
  • Subject signed informed consent

Exclusion Criteria:

  • Subjects with implantable Pacemakers or Defibrillators
  • Subjects with Wolff-Parkinson-White Syndrome

Information from the National Library of Medicine

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 identifier (NCT number): NCT00310622

Contact: David Rosenman, MD +972-50-8685923
Contact: Nechi Almogy, MD +972-54-6602697

Cardiology Department, Shaarey Zedek Hospital Recruiting
Jerusalem, Israel
Sponsors and Collaborators
BSP Biological Signal Processing Ltd.
Principal Investigator: David Rosenmann, MD Shaarey Zedek Hospital, Jerusalem, Israel

Additional Information: Identifier: NCT00310622     History of Changes
Other Study ID Numbers: SHZ01
First Posted: April 4, 2006    Key Record Dates
Last Update Posted: March 1, 2007
Last Verified: February 2007

Keywords provided by BSP Biological Signal Processing Ltd.:

Additional relevant MeSH terms:
Myocardial Ischemia
Coronary Artery Disease
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arterial Occlusive Diseases
Cardiotonic Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents