WOMENS ANGIOGRAPHIC VITAMIN & ESTROGEN (WAVE) TRIAL

多项观察性研究表明，绝经后激素替代疗法(HRT)和抗氧化维生素疗法(大剂量维卡因C和E)可能通过延缓动脉粥样硬化冠状动脉斑块的进展来限制心血管发病率和死亡率。然而，几乎没有证据可用，因为随机临床试验尚未完成。如果证明激素替代疗法或维生素对冠状动脉疾病的进展有积极影响，它可能会对全球数百万患有这种常见疾病的女性的健康产生深远的影响。WAVE(女性血管造影维生素和雌激素)研究是由NHLBI赞助的一项多中心临床试验，旨在确定女性激素替代疗法(HRT)和/或抗氧化性维生素疗法(维生素C和E)是否可以限制至少有一条非干预性冠状动脉狭窄在基线水平为15%-70%的绝经后妇女的冠状动脉疾病的进展。参与者在基线时接受冠状动脉造影术以及乳房X光检查和妇科检查，然后被随机分为(1)HRT组；(2)单纯维生素C和E组；(3)HRT和维生素组；或(4)安慰剂组。受试者每年重复进行心脏病学和妇产科随访，然后在3年后“退出”冠状动脉造影术。UAB是参与这一项目的5个临床中心之一，其目标是在1998年12月之前随机选择400-450名绝经后妇女。虽然大部分WAVE是在门诊实施的，但我们会利用GCRC的住院病床，供偶尔需要在基线或3年随访时进行冠状动脉造影术后过夜观察的患者使用。

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.