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Women's Ischemia Syndrome Evaluation (WISE)

Clinical Trials URL: http://www.clinicaltrials.gov/ct/sh...
Study Type: Epidemiology Study
Prepared on October 13, 2008
Last Updated on January 15, 2008
Study Dates: 2001-2007
Consent: Unrestricted Consent
Commercial Use Restrictions: No
NHLBI Division: DCVS
Collection Type: Open BioLINCC Study - See bottom of this webpage for request information

Objectives

This 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

Women tend to have a higher prevalence of chest pain than men, yet a lower prevalence of epicardial coronary stenoses, and diagnostic tests such as exercise-induced ECG changes tend to have a higher false-positive rate in women than in men. Thus, accurate diagnosis of ischemic heart disease in women is a major challenge to physicians. In addition, prognosis in women with abnormal diagnostic tests is largely unknown 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.

Subjects

In Phase I (1996-1997), a pilot phase, 256 women were studied. During Phase II (1997-1999) angiographic and baseline data were collected on an additional 680 women to bring total enrollment to 936. Baseline data was also collected on a reference population of 70 women. Women eligible for participation are greater than 18 years of age, are undergoing a clinically indicated angiogram as part of regular medical care for chest pain or suspected myocardial ischemia. Exclusion criteria included comorbidity that would compromise one-year followup, pregnancy, contraindications to diagnostic testing, cardiomyopathy, NYHA class IV congestive heart failure, congenital heart disease, or significant valvular disease.

Conclusions

Among women without CAD, abnormal Magnetic Resonance Spectroscopy (MRS) consistent with myocardial ischemia predicted cardiovascular outcome, notably higher rates of anginal hospitalization, repeat catherization, and greater treatment costs (Circulation 2004; 109:2993-9).


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