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Assessment of HyperQ Signal for Detecting Ischemia During Dobutamine Stress ECG

Information source: BSP Biological Signal Processing Ltd.
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Myocardial Ischemia

Intervention: HyperQ Signal recording (Device)

Phase: Phase 3

Status: Recruiting

Sponsored by: BSP Biological Signal Processing Ltd.

Official(s) and/or principal investigator(s):
David Rosenmann, MD, Principal Investigator, Affiliation: Shaarey Zedek Hospital, Jerusalem, Israel

Overall contact:
David Rosenman, MD, Phone: +972-50-8685923

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.

Clinical Details

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Primary outcome: HyperQ Signal recorded during the DES Test

Secondary outcome: DES Outcome/ Angiography

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

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

David Rosenman, MD, Phone: +972-50-8685923

Cardiology Department, Shaarey Zedek Hospital, Jerusalem, Israel; Recruiting
Additional Information

Biological Signal Processing Ltd.

Starting date: March 2006
Last updated: February 28, 2007

Page last updated: August 20, 2015

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