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
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