- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00850486
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: David Rosenmann, MD
- Phone Number: 972-2-6555974
- Email: rosenmann@szmc.org.il
Study Locations
-
-
-
Jerusalem, Israel
- Recruiting
- Shaare Zedek Medical Center
-
Sub-Investigator:
- David Rosenmann, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
HyperQ results from the exercise test vs. angiography results
Time Frame: every 25 patients
|
every 25 patients
|
Collaborators and Investigators
Investigators
- Principal Investigator: Dan Tzivoni, Professor, Shaare Zedek Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SHZ_02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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