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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 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
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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

Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: February 24, 2009
Last Updated: February 24, 2009
Health Authority: Israel: Ministry of Health

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:
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Ischemia
Coronary Disease
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 21, 2013