Diagnostic Benefits of HyperQTM vs. Conventional ECG Stress Test. Comparison of HyperQ vs. Stress ECG in Women Before Angiography
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|ClinicalTrials.gov Identifier: NCT00850486|
Recruitment Status : Unknown
Verified February 2009 by BSP Biological Signal Processing Ltd..
Recruitment status was: Recruiting
First Posted : February 25, 2009
Last Update Posted : February 25, 2009
|Condition or disease||Intervention/treatment||Phase|
|Ischemic Heart Disease||Device: Exercise test with HyperQ technology||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||The Diagnostic Benefits of HyperQTM vs. Conventional ECG During Stress Test. A Comparison Study in Women Referred to Angiography.|
|Study Start Date :||August 2008|
|Estimated Primary Completion Date :||December 2009|
|Estimated Study Completion Date :||March 2010|
- 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
- HyperQ results from the exercise test vs. angiography results [ Time Frame: every 25 patients ]
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
|Contact: David Rosenmann, MDfirstname.lastname@example.org|
|Shaare Zedek Medical Center||Recruiting|
|Sub-Investigator: David Rosenmann, MD|
|Principal Investigator:||Dan Tzivoni, Professor||Shaare Zedek Medical Center|