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Assessment of HyperQ Signal for Detecting Ischemia During Dobutamine Stress ECG

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

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00310622
Enrollment
150
Registered
2006-04-04
Start date
2006-03-31
Completion date
2007-02-28
Last updated
2007-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Ischemia

Keywords

HyperQ, Ischemia, dobutamine

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.

Interventions

DEVICEHyperQ Signal recording

Sponsors

BSP Biological Signal Processing Ltd.
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
HyperQ Signal recorded during the DES Test

Secondary

MeasureTime frame
DES Outcome/ Angiography

Countries

Israel

Contacts

Primary ContactDavid Rosenman, MD
+972-50-8685923
Backup ContactNechi Almogy, MD
nechi@bsp.co.il+972-54-6602697

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026