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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2009 by BSP Biological Signal Processing Ltd..
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00850486
First Posted: February 25, 2009
Last Update Posted: February 25, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
BSP Biological Signal Processing Ltd.
  Purpose
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.

Condition Intervention Phase
Ischemic Heart Disease Device: Exercise test with HyperQ technology Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: The Diagnostic Benefits of HyperQTM vs. Conventional ECG During Stress Test. A Comparison Study in Women Referred to Angiography.

Resource links provided by NLM:


Further study details as provided by BSP Biological Signal Processing Ltd.:

Primary Outcome Measures:
  • HyperQ results from the exercise test vs. angiography results [ Time Frame: every 25 patients ]

Estimated Enrollment: 200
Study Start Date: August 2008
Estimated Study Completion Date: March 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Exercise test with HyperQ technology
    High frequency components of the QRS complex within the ECG signal are analyzed off-line to provide an indication of ischemia induced depolarization abnormalities
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00850486


Contacts
Contact: David Rosenmann, MD 972-2-6555974 rosenmann@szmc.org.il

Locations
Israel
Shaare Zedek Medical Center Recruiting
Jerusalem, Israel
Sub-Investigator: David Rosenmann, MD         
Sponsors and Collaborators
BSP Biological Signal Processing Ltd.
Investigators
Principal Investigator: Dan Tzivoni, Professor Shaare Zedek Medical Center
  More Information

Responsible Party: Professor Dan Tzivoni - Head of Cardiology Department, Shaare Zedek Medical Center
ClinicalTrials.gov Identifier: NCT00850486     History of Changes
Other Study ID Numbers: SHZ_02
First Submitted: February 24, 2009
First Posted: February 25, 2009
Last Update Posted: February 25, 2009
Last Verified: February 2009

Keywords provided by BSP Biological Signal Processing Ltd.:
women
ischemic heart disease
high frequency ECG
exercise stress testing
signal processing
ischemic heart disease in women

Additional relevant MeSH terms:
Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases