WOMENS ANGIOGRAPHIC VITAMIN & ESTROGEN (WAVE) TRIAL

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Multiple observational studies have suggested that post-menopausal hormone replacement therapy (HRT) and antioxidant vitamin therapy (high-dose Vicamins C and E) may limit cardiovascular morbidity and mortality, possibly by retarding the progression of the atherosclerotic coronary artery plaque. However, little proof is available, because randomized clinical trials have not yet been completed. Should it be proved that either HRT or vitamins impact favorably on the progression of coronary artery disease, it could have profound implications for the health of millions of women worldwide afflicted with this common disease. The WAVE (Women's Angiographic Vitamin & Estrogen) Study is an NHLBI-sponsored multicenter clinical trial designed to determine whether female hormone replacement therapy (HRT) and/or antioxidant vitamin therapy (Vitamins C and E) can limit the progression of coronary artery disease in post-menopausal women having at least one non-intervened coronary artery with stenosis at baseline of 15-70%. Participants undergo coronary arteriography at baseline along with mammogram and GYN evaluation and are then randomized to (1) HRT alone; (2) Vitamin C and E alone; (3) both HRT and vitamins; or (4) placebo. Subjects undergo repeat cardiology and GYN follow-up annually and then "exit" coronary arteriography after 3 years. UAB is one of 5 clinical centers participating in this project whose goal is to randomize 400-450 postmenopausal women by December, 1998. Although the majority of WAVE is implemented in the outpatient clinics, we would utilize the inpatient beds of the GCRC for occasional patients needing overnight observation after their coronary arteriogram at either baseline or at 3-year followup.