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Assessment of HyperQ Signal for Detecting Ischemia During Dobutamine Stress ECG

B

BSP Biological Signal Processing

Status and phase

Unknown
Phase 3

Conditions

Myocardial Ischemia

Treatments

Device: HyperQ Signal recording

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

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.

Full 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.

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Central trial contact

Nechi Almogy, MD; David Rosenman, MD

Data sourced from clinicaltrials.gov

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