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 because the information has not been verified recently.
Verified February 2009 by BSP Biological Signal Processing Ltd..
Recruitment status was  Recruiting
Sponsor:
Information provided by:
BSP Biological Signal Processing Ltd.
ClinicalTrials.gov Identifier:
NCT00850486
First received: February 24, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted

February 24, 2009
February 24, 2009
August 2008
December 2009   (final data collection date for primary outcome measure)
HyperQ results from the exercise test vs. angiography results [ Time Frame: every 25 patients ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
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Diagnostic Benefits of HyperQTM vs. Conventional ECG Stress Test. Comparison of HyperQ vs. Stress ECG in Women Before Angiography
The Diagnostic Benefits of HyperQTM vs. Conventional ECG During Stress Test. A Comparison Study in Women Referred to Angiography.

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.

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.

Interventional
Phase 4
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Ischemic Heart Disease
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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
March 2010
December 2009   (final data collection date for primary outcome measure)

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
Female
Not Provided
No
Contact: David Rosenmann, MD 972-2-6555974 rosenmann@szmc.org.il
Israel
 
NCT00850486
SHZ_02
No
Professor Dan Tzivoni - Head of Cardiology Department, Shaare Zedek Medical Center
BSP Biological Signal Processing Ltd.
Not Provided
Principal Investigator: Dan Tzivoni, Professor Shaare Zedek Medical Center
BSP Biological Signal Processing Ltd.
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP