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The Women's Ischemia Syndrome Evaluation (WISE) study: protocol design, methodology and feasibility report
C N Merz1, S F Kelsey, C J Pepine
1Department of Medicine, Cedars-Sinai Research Institute, Cedars-Sinai Medical Center, Los Angeles, California, USA.
Journal of the American College of Cardiology
|May 20, 1999
Summary
The Women's Ischemia Syndrome Evaluation (WISE) study established a safe and feasible protocol for diagnosing ischemic heart disease in women. This research aims to improve diagnostic accuracy and understand the role of reproductive hormones in women's heart conditions.
Area of Science:
- Cardiovascular Medicine
- Women's Health
- Diagnostic Imaging
Background:
- Accurate diagnosis of ischemic heart disease in women presents a significant clinical challenge.
- The influence of reproductive hormones on diagnostic uncertainty in women's cardiac conditions remains unexplored.
- The pathophysiology and clinical significance of myocardial ischemia without epicardial coronary stenoses are not well understood.
Purpose of the Study:
- To optimize symptom evaluation and diagnostic testing for ischemic heart disease in women.
- To investigate the mechanisms underlying symptoms and myocardial ischemia in women, particularly in the absence of significant coronary artery stenoses.
- To evaluate the impact of reproductive hormones on symptom presentation and diagnostic test responses in women with suspected heart disease.
Main Methods:
- The Women's Ischemia Syndrome Evaluation (WISE) study employed a common core dataset including demographics, clinical data, symptoms, psychosocial variables, and cardiac imaging.
- Advanced cardiovascular assessments included coronary angiography, ventriculography, brachial artery reactivity testing, and electrocardiographic monitoring.
- Women were followed for at least one year to assess clinical events and symptom status, with site-specific complementary physiologic and functional assessments.
Main Results:
- Phase I of the WISE study, involving 256 women from 1996-1997, demonstrated the safety and feasibility of the WISE protocol.
- The protocol effectively identified symptomatic women, including those with and without significant epicardial coronary artery stenoses.
- Pilot data confirmed the study's ability to enroll and assess the target population.
Conclusions:
- The WISE study is defining contemporary diagnostic standards for evaluating women with suspected ischemic heart disease.
- The ongoing Phase II (1997-1999) expanded enrollment to 680 women, with a total planned enrollment of 936.
- Future work, including Phase III (2000), will focus on patient follow-up, comprehensive data analysis, and dissemination through a National Institutes of Health workshop.