Assessment of HyperQ Signal for Detecting Ischemia During Dobutamine Stress ECG

Phase 3

• Conditions: Myocardial Ischemia

• Registration Number: NCT00310622
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2006-03
• Study First Submitted: 2006-04-02
• Study First Submitted QC: 2006-04-03
• Study First Posted: 2006-04-04
• Status Verified: 2007-02
• Study Completion: 2007-02
• Last Update Submitted: 2007-02-28
• Last Update Posted: 2007-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
HyperQ Signal recorded during the DES Test

Secondary Outcome Measures

Name	Time	Method
DES Outcome/ Angiography

Trial Locations

Locations (1)

Cardiology Department, Shaarey Zedek Hospital; 🇮🇱 Jerusalem, Israel