CLINICAL STUDIES
The Women’s Ischemia Syndrome Evaluation (WISE) Study: protocol design, methodology and feasibility report
C. Noel Bairey Merz, MD, FACC*  ,
Sheryl F. Kelsey, PhD ,
Carl J. Pepine, MD, FACC ,
Nathaniel Reichek, MD, FACC||,
Steven E. Reis, MD, FACC¶,
William J. Rogers, MD, FACC#,
Barry L. Sharaf, MD, FACC**,
George Sopko, MD for the WISE Study Group
* Division of Cardiology, Department of Medicine, Cedars-Sinai Research Institute, Cedars-Sinai Medical Center, Los Angeles, California, USA
Department of Medicine, University of California School of Medicine, Los Angeles, California, USA
Department of Epidemiology, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, Pennsylvania, USA
Division of Cardiology, Department of Medicine, University of Florida, Gainesville, Florida, USA
|| Division of Cardiology, Department of Medicine, Allegheny General Hospital, MCP-Hahnemann School of Medicine, Pittsburgh, Pennsylvania, USA
¶ Division of Cardiology, Department of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA
# Division of Cardiology, Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama, USA
** Rhode Island Hospital, Providence, Rhode Island, USA
Division of Heart and Vascular Diseases, National Heart, Lung and Blood Institute, National Institutes of Health, Bethesda, Maryland, USA
Manuscript received June 26, 1998;
revised manuscript received December 3, 1998,
accepted January 21, 1999.
Reprint requests and correspondence: Dr. C. Noel Bairey Merz, c/o WISE Coordinating Center, University of Pittsburgh, 127 Parran Hall, Graduate School of Public Health, 130 DeSoto St., Pittsburgh, Pennsylvania 15261
OBJECTIVES
The Women’s Ischemia Syndrome Evaluation (WISE) is a National Heart, Lung and Blood Institute–sponsored, four-center study designed to: 1) optimize symptom evaluation and diagnostic testing for ischemic heart disease; 2) explore mechanisms for symptoms and myocardial ischemia in the absence of epicardial coronary artery stenoses, and 3) evaluate the influence of reproductive hormones on symptoms and diagnostic test response.
BACKGROUND
Accurate diagnosis of ischemic heart disease in women is a major challenge to physicians, and the role reproductive hormones play in this diagnostic uncertainty is unexplored. Moreover, the significance and pathophysiology of ischemia in the absence of significant epicardial coronary stenoses is unknown.
METHODS
The WISE common core data include demographic and clinical data, symptom and psychosocial variables, coronary angiographic and ventriculographic data, brachial artery reactivity testing, resting/ambulatory electrocardiographic monitoring and a variety of blood determinations. Site-specific complementary methods include physiologic and functional cardiovascular assessments of myocardial perfusion and metabolism, ventriculography, endothelial vascular function and coronary angiography. Women are followed for at least 1 year to assess clinical events and symptom status.
RESULTS
In Phase I (1996–1997), a pilot phase, 256 women were studied. These data indicate that the WISE protocol is safe and feasible for identifying symptomatic women with and without significant epicardial coronary artery stenoses.
CONCLUSIONS
The WISE study will define contemporary diagnostic testing to evaluate women with suspected ischemic heart disease. Phase II (1997–1999) is ongoing and will study an additional 680 women, for a total WISE enrollment of 936 women. Phase III (2000) will include patient follow-up, data analysis and a National Institutes of Health WISE workshop.
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Abbreviations and Acronyms
| | ECG | = electrocardiogram/electrocardiographic | | MRI | = magnetic resonance imaging | | SPECT | = single photon emission computed tomography | | WISE | = Women’s Ischemia Syndrome Evaluation |
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