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Assessment of HyperQ Signal for Detecting Ischemia During Dobutamine Stress ECG

Primary Purpose

Myocardial Ischemia

Status
Unknown status
Phase
Phase 3
Locations
Israel
Study Type
Interventional
Intervention
HyperQ Signal recording
Sponsored by
BSP Biological Signal Processing Ltd.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Myocardial Ischemia focused on measuring HyperQ, Ischemia, dobutamine

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cardiology Department, Shaarey Zedek HospitalRecruiting

Outcomes

Primary Outcome Measures

HyperQ Signal recorded during the DES Test

Secondary Outcome Measures

DES Outcome/ Angiography

Full Information

First Posted
April 2, 2006
Last Updated
February 28, 2007
Sponsor
BSP Biological Signal Processing Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00310622
Brief Title
Assessment of HyperQ Signal for Detecting Ischemia During Dobutamine Stress ECG
Official Title
An Assessment of the HyperQ Signal for Detecting Ischemia During Dobutamine Stress Echocardiography (DSE)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2007
Overall Recruitment Status
Unknown status
Study Start Date
March 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
BSP Biological Signal Processing Ltd.

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Ischemia
Keywords
HyperQ, Ischemia, dobutamine

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
HyperQ Signal recording
Primary Outcome Measure Information:
Title
HyperQ Signal recorded during the DES Test
Secondary Outcome Measure Information:
Title
DES Outcome/ Angiography

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Rosenman, MD
Phone
+972-50-8685923
First Name & Middle Initial & Last Name or Official Title & Degree
Nechi Almogy, MD
Phone
+972-54-6602697
Email
nechi@bsp.co.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Rosenmann, MD
Organizational Affiliation
Shaarey Zedek Hospital, Jerusalem, Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiology Department, Shaarey Zedek Hospital
City
Jerusalem
Country
Israel
Individual Site Status
Recruiting

12. IPD Sharing Statement

Links:
URL
http://www.bsp.co.il
Description
Biological Signal Processing Ltd.

Learn more about this trial

Assessment of HyperQ Signal for Detecting Ischemia During Dobutamine Stress ECG

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