POSTMENOPAUSAL HORMONE REPLACEMENT THERAPY AFTER CABG
POSTMENOPAUSAL HORMONE REPLACEMENT THERAPY AFTER CABG
批准号:
6281943
负责人:
PAMELA OUYANG
金额:
$5.69万
依托单位:
依托单位国家:
美国
项目类别:
财政年份:
1998
资助国家:
美国
项目状态:
已结题
起止时间:
1998-07-10 至 1998-11-30
中文摘要
冠状动脉粥样硬化是美国女性死亡的主要原因。
虽然冠状动脉搭桥手术减少了症状和临床
心脏缺血的证据,它不会改变潜在的过程。
患者可能会因隐静脉移植而出现复发症状
闭塞、移植物动脉粥样硬化或潜在冠状动脉病变进展
疾病降低冠状动脉粥样硬化发生率的干预措施
进展将使旁路手术后的妇女受益匪浅,
可能对所有患有动脉粥样硬化疾病的女性有益。一些
观察性研究表明,绝经后雌激素替代疗法
激素替代疗法(HRT)可将心脏病发病率降低高达50%。HRT的好处
在已确诊冠心病的女性中,尚未进行过研究。的
激素替代疗法延缓隐静脉移植物生长的疗效观察
动脉粥样硬化是未知的。这个随机的,双盲的,安慰剂-
对照试验检验了HRT在
冠状动脉搭桥手术将延迟移植物的发育
动脉粥样硬化和减少移植物闭塞的发生。妇女将
随机接受安慰剂或HRT +17 β-雌二醇
醋酸甲羟孕酮(或17 β-雌二醇,如果子宫切除术后)
手术后4个月内。移植静脉粥样硬化的研究进展
将使用定量冠状动脉造影测量,
血管内超声评估疾病的严重程度和范围。
研究将在随机化后6个月和3.5年进行。我们
应确定HRT对主要结局变量的影响,
静脉移植物中动脉粥样硬化的严重程度和范围的变化超过
3.5多年的治疗。我们假设,
血小板活化,纤维蛋白原与血小板结合,血管
反应性、凝血和纤溶因子以及脂蛋白
组成预测移植物闭塞和移植物
动脉粥样硬化将测量HRT对这些因素的影响。的
一项提案还验证了HRT发挥其有益作用的假设
除了传统的风险因素外,
包括脂质和脂蛋白谱。这些风险的影响
HRT对移植肾早期闭合率的影响
(在6个月的冠状动脉造影中确定)将进行评估。
英文摘要
Coronary atherosclerosis is the major cause of death in women in the USA.
While coronary artery bypass surgery decreases symptomatic and clinical
evidence of cardiac ischemia it does not alter the underlying process.
Patients may develop recurrent symptoms due to saphenous vein graft
occlusion, graft atherosclerosis, or progression of underlying coronary
disease. Interventions that reduce the rate of coronary atherosclerosis
progression would significantly benefit women following bypass surgery and
possibly benefit all women with atherosclerotic disease. Some
observational studies suggest that postmenopausal estrogen replacement
therapy (HRT) reduces cardiac morbidity by up to 50%. The benefit of HRT
in women with established coronary disease has not been studied. The
efficacy of HRT to delay the development of saphenous graft
atherosclerosis is unknown. This randomized, double-masked, placebo-
controlled trial tests the hypothesis that HRT started shortly after
coronary bypass surgery will delay the development of graft
atherosclerosis and reduce the occurrence of graft occulsion. Women will
be randomized to placebo or HRT with 17 beta-estradiol plus
medroxyprogesterone acetate (or 17 beta-estradiol if post hysterectomy)
within 4 months of surgery. The development of vein graft atherosclerosis
will be measured using quantitative coronary angiographic and
intravsacular ultrasound assessment of disease severity and extent.
Studies will be performed 6 months and 3.5 years after randomization. We
shall determine the influence of HRT on the primary outcome variables of
the change in severity and extent of atherosclerosis in vein grafts over
3.5 years of therapy. We postulate that the pathophysiologic mechanims of
platelet activation, fribrinogen binding to platelets, vascular
reactivity, coagulation and fibrinolytic factors and lipoprotein
composition predict the occurrence of graft occlusion and graft
atherosclerosis. The effect of HRT on these factors will be measured. The
proposal also tests the hypothesis that HRT exerts its beneficial effects
on these risk factors in addition to more traditional risk factors
including lipids and lipoprotein profile. The influence of these risk
factors and the effect of HRT on the frequency of early graft closure
(identified on a 6-month coronary angiogram) will be assessed.
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海外基金