Assessment of HyperQ Signal for Detecting Ischemia During Dobutamine Stress ECG

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2007 by BSP Biological Signal Processing Ltd..
Recruitment status was  Recruiting
Sponsor:
Information provided by:
BSP Biological Signal Processing Ltd.
ClinicalTrials.gov Identifier:
NCT00310622
First received: April 2, 2006
Last updated: February 28, 2007
Last verified: February 2007
  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 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: An Assessment of the HyperQ Signal for Detecting Ischemia During Dobutamine Stress Echocardiography (DSE)

Resource links provided by NLM:


Further study details as provided by BSP Biological Signal Processing Ltd.:

Primary Outcome Measures:
  • HyperQ Signal recorded during the DES Test

Secondary Outcome Measures:
  • DES Outcome/ Angiography

Estimated Enrollment: 150
Study Start Date: March 2006
Estimated Study Completion Date: February 2007
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00310622

Contacts
Contact: David Rosenman, MD +972-50-8685923
Contact: Nechi Almogy, MD +972-54-6602697 nechi@bsp.co.il

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00310622     History of Changes
Other Study ID Numbers: SHZ01
Study First Received: April 2, 2006
Last Updated: February 28, 2007
Health Authority: Israel: Ethics Commission

Keywords provided by BSP Biological Signal Processing Ltd.:
HyperQ
Ischemia
dobutamine

Additional relevant MeSH terms:
Myocardial Ischemia
Coronary Artery Disease
Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Pathologic Processes
Dobutamine
Cardiotonic Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Sympathomimetics
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

ClinicalTrials.gov processed this record on August 21, 2014