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Women's Ischemia Syndrome Evaluation - WISE
Description:
The goal of the National Heart, Lung and Blood Institute–sponsored Women’s Ischemia Syndrome Evaluation (WISE) study is 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.
Hypothesis:
The WISE study sought to identify causes for gender-related differences in disease detection, treatment, and outcomes of ischemic heart disease in women.
Study Design
Study Design:
Patients Screened: 1,979 in Phase I
Patients Enrolled: 308 in Phase I
Mean Follow Up: at least 1 year
Mean Patient Age: mean age 59 years in Phase 1
Female: 100
Mean Ejection Fraction: Mean 68% (range 23% to 86%)
Patient Populations:
Women age >=18 years and undergoing a clinically indicated coronary angiogram as part of their regular medical care for chest pain symptoms or suspected myocardial ischemia.
Exclusions:
Comorbidity which compromises 1-year follow-up, pregnancy, contraindications to provocative diagnostic testing, cardiomyopathy, New York Heart Association class IV CHF, recent MI, significant valvular or congenital heart disease and a language barrier to questionnaire testing.
Drug/Procedures Used:
Women were enrolled in the WISE study at four sites. Data collected included demographic and clinical data, symptom and psychosocial variables, coronary angiographic (assessed by a core laboratory) and ventriculographic data, brachial artery reactivity testing, resting/ambulatory electrocardiographic monitoring and a variety of blood determinations. Women are followed to assess clinical events and symptom status for at least 1 year.
Principal Findings:
Among the women in the pilot phase of the WISE study, 85% were postmenopausal, 3% were perimenopausal and 11% were premenopausal; 38% were users of hormone replacement therapy. Chest pain symptoms were typical angina in 35% of patients and atypical in 65%, and 45% of patients reported daily or almost daily symptoms. Significant coronary artery stenosis (>=50%) in any major coronary artery was present in 31% of patients, mild stenosis (20% to 49%) was present in 32% of patients, and 37% of patients had no (<20%) stenoses.
Interpretation:
The pilot phase of the WISE study demonstrated that that the WISE protocol was safe and feasible for identifying symptomatic women with and without significant epicardial coronary artery stenoses. Data from the larger Phase II study are pending.
References:
Merz CN, Kelsey SF, Pepine CJ, et al. The Women's Ischemia Syndrome Evaluation (WISE) study: protocol design, methodology and feasibility report. J Am Coll Cardiol 1999;33:1453-61.
Keywords: Symptom Assessment, Coronary Artery Disease, Brachial Artery, Diagnostic Tests, Routine, Coronary Stenosis, Coronary Angiography, Demography, Chest Pain, Constriction, Pathologic, Electrocardiography, Ambulatory, Hormone Replacement Therapy
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