Status:
COMPLETED
The WOMEN Study: What is the Optimal Method for Ischemia Evaluation in WomeN?
Lead Sponsor:
Hartford Hospital
Collaborating Sponsors:
GE Healthcare
Conditions:
Coronary Artery Disease
Heart Disease
Eligibility:
FEMALE
60+ years
Brief Summary
The purpose of this study is to compare two types of exercise stress testing to find the best method for detecting heart disease in women.
Detailed Description
Coronary artery disease remains the leading cause of morbidity and mortality in women accounting for more than 250,000 deaths per year. While mortality rates have decreased significantly in men during...
Eligibility Criteria
Inclusion
- \- Women 60 years of age and older presenting for the evaluation of chest pain, or other anginal equivalent symptoms while at an intermediate-high pretest risk for IHD
Exclusion
- Women with known CAD
- Women scoring \<5 METs on the DASI
- Nursing or pregnant females
- Nuclear medicine study within the preceding 10 days
- Electrocardiographic abnormalities precluding interpretation of peak stress changes including: Left bundle branch block, electronic ventricular pacemaker, left ventricular hypertrophy, WPW, and resting ST-T wave changes. Additionally, patients currently on digoxin therapy
- Significant valvular heart disease (i.e. severe aortic stenosis or regurgitation, or severe mitral insufficiency)
- Hemodynamic instability (blood pressure \>210/110 ml/Hg or \<90/60 mm/Hg)
- Left ventricular systolic dysfunction with a left ventricular ejection fraction less than 30 %
- Unavailability for long-term follow-up
Key Trial Info
Start Date :
June 1 2004
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
824 Patients enrolled
Trial Details
Trial ID
NCT00282711
Start Date
June 1 2004
End Date
December 1 2010
Last Update
August 1 2012
Active Locations (43)
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1
Southwest Heart
Tucson, Arizona, United States, 85715
2
Cardiology Consultants of Orange Country Medical Group, Inc
Anaheim, California, United States, 92801
3
Escondido Cardiology Associates
Escondido, California, United States, 92025
4
Mission Internal Medical Group
Mission Viejo, California, United States, 92691