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Diagnostic Benefits of HyperQTM vs. Conventional ECG Stress Test. Comparison of HyperQ vs. Stress ECG in Women Before Angiography

Primary Purpose

Ischemic Heart Disease

Status
Unknown status
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
Exercise test with HyperQ technology
Sponsored by
BSP Biological Signal Processing Ltd.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Ischemic Heart Disease focused on measuring women, ischemic heart disease, high frequency ECG, exercise stress testing, signal processing, ischemic heart disease in women

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • A woman who was referred to angiography.
  • A woman who is able (i.e. no contraindications) to perform an exercise stress test
  • A woman who signed an informed consent form.

Exclusion Criteria:

  • Contraindications for an exercise test
  • Wolff-Parkinson-White (pre-excitation) syndrome.
  • Left Bundle branch block, Complete Right bundle branch block or QRS duration > 120 ms, change in QRS morphology during exercise
  • Atrial Fibrillation or significant ventricular arrhythmia
  • Treatment with Digoxin
  • Pacemaker
  • Having taken beta blockers within 24 hours before the exercise test
  • Pregnancy or suspected pregnancy

Sites / Locations

  • Shaare Zedek Medical CenterRecruiting

Outcomes

Primary Outcome Measures

HyperQ results from the exercise test vs. angiography results

Secondary Outcome Measures

Full Information

First Posted
February 24, 2009
Last Updated
February 24, 2009
Sponsor
BSP Biological Signal Processing Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00850486
Brief Title
Diagnostic Benefits of HyperQTM vs. Conventional ECG Stress Test. Comparison of HyperQ vs. Stress ECG in Women Before Angiography
Official Title
The Diagnostic Benefits of HyperQTM vs. Conventional ECG During Stress Test. A Comparison Study in Women Referred to Angiography.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Unknown status
Study Start Date
August 2008 (undefined)
Primary Completion Date
December 2009 (Anticipated)
Study Completion Date
March 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
BSP Biological Signal Processing Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to verify the efficiency of the HyperQ technology compared with standard ECG analysis in detecting exercise induced ischemia in women who are referred to coronary angiography.
Detailed Description
Cardiovascular disease (CVD) is the leading cause of mortality in women. In fact, CVD is responsible for a third of all deaths of women worldwide and half of all deaths of women over 50 years of age in developing countries. Historically, women have been underrepresented in clinical trials. The lack of good trial evidence concerning sex-specific outcomes has led to assumptions about CVD treatment in women, which in turn may have resulted in inadequate diagnoses and suboptimal management, greatly affecting outcomes. This knowledge gap may also explain why cardiovascular health in women is not improving as fast as that of men. Over the last decades, mortality rates in men have steadily declined, while those in women remained stable. The treadmill exercise test is the classic initial investigation for the diagnosis of coronary artery disease (CAD), and significant ST depression on the ECG is the commonly used indicator of a positive test. Compared with men, in women it is known that ST depression is less likely to be associated with CAD. False positive rates of treadmill exercise testing have been reported to be as high as 67%, while positive predictive value is around 48-50%. Coronary angiography is one of the most frequently performed procedures in women; however, non-obstructive (ie, <50% stenosis) CAD is frequently reported. Additionally, approximately 30% of women undergoing PTCA because of a positive exercise test are found to have normal coronary arteries. A successful outcome in the current study will significantly improve non-invasive diagnosis of CAD in women and may reduce the number of unnecessary invasive procedures performed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Heart Disease
Keywords
women, ischemic heart disease, high frequency ECG, exercise stress testing, signal processing, ischemic heart disease in women

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Exercise test with HyperQ technology
Intervention Description
High frequency components of the QRS complex within the ECG signal are analyzed off-line to provide an indication of ischemia induced depolarization abnormalities
Primary Outcome Measure Information:
Title
HyperQ results from the exercise test vs. angiography results
Time Frame
every 25 patients

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: A woman who was referred to angiography. A woman who is able (i.e. no contraindications) to perform an exercise stress test A woman who signed an informed consent form. Exclusion Criteria: Contraindications for an exercise test Wolff-Parkinson-White (pre-excitation) syndrome. Left Bundle branch block, Complete Right bundle branch block or QRS duration > 120 ms, change in QRS morphology during exercise Atrial Fibrillation or significant ventricular arrhythmia Treatment with Digoxin Pacemaker Having taken beta blockers within 24 hours before the exercise test Pregnancy or suspected pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Rosenmann, MD
Phone
972-2-6555974
Email
rosenmann@szmc.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dan Tzivoni, Professor
Organizational Affiliation
Shaare Zedek Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Rosenmann, MD

12. IPD Sharing Statement

Learn more about this trial

Diagnostic Benefits of HyperQTM vs. Conventional ECG Stress Test. Comparison of HyperQ vs. Stress ECG in Women Before Angiography

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