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NCT00310622 Clinical Trial

Assessment of HyperQ Signal for Detecting Ischemia During Dobutamine Stress ECG

Myocardial Ischemia Clinical Trial

Official title:
An Assessment of the HyperQ Signal for Detecting Ischemia During Dobutamine Stress Echocardiography (DSE)

Clinical Trial Details — Status: Unknown status

Administrative data
NCT number NCT00310622
Other study ID # SHZ01
Secondary ID
Status Unknown status
Phase Phase 3
First received April 2, 2006
Last updated February 28, 2007
Start date March 2006
Est. completion date February 2007

Study information
Verified date February 2007
Source BSP Biological Signal Processing Ltd.
Contact David Rosenman, MD
Phone +972-50-8685923
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Unknown status
Enrollment 150
Est. completion date February 2007
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• HyperQ Signal recording

Locations
Country Name City State
Israel Cardiology Department, Shaarey Zedek Hospital Jerusalem

Sponsors (1)
Lead Sponsor Collaborator
BSP Biological Signal Processing Ltd.

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary HyperQ Signal recorded during the DES Test
Secondary DES Outcome/ Angiography
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