Assessment of HyperQ Signal for Detecting Ischemia During Dobutamine Stress ECG

NCT ID: NCT00310622

Last Updated: 2007-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2007-02-28

Brief Summary

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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

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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.

Conditions

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Myocardial Ischemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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HyperQ Signal recording

Intervention Type DEVICE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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BSP Biological Signal Processing Ltd.

INDUSTRY

Sponsor Role lead

Principal Investigators

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David Rosenmann, MD

Role: PRINCIPAL_INVESTIGATOR

Shaarey Zedek Hospital, Jerusalem, Israel

Locations

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Cardiology Department, Shaarey Zedek Hospital

Jerusalem, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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David Rosenman, MD

Role: CONTACT

+972-50-8685923

Nechi Almogy, MD

Role: CONTACT

+972-54-6602697

Related Links

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http://www.bsp.co.il

Biological Signal Processing Ltd.

Other Identifiers

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SHZ01

Identifier Type: -

Identifier Source: org_study_id

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