WISE Ancillary Study Data Analyses: Efficacy of Hormone Replacement on Myocardial Ischemia in Postmenopausal Women With Normal/Minimal Coronary Artery Disease: Data Analysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Inducible Myocardial Ischemia
研究概览
简要总结
The goal of the main trial was to evaluate the effect of low dose hormone replacement therapy with 1 mg norethindrone/10mcg ethinyl estradiol in postmenopausal women with a history of chest discomfort, myocardial ischemia and no obstructive CAD. For the purposes of this study as a core lab coordinating center, the investigators will be performing P31 MRS core lab analyses; hormone core lab analyses; lipid core lab analyses; glucose, insulin and HOMA core lab analyses; exercise stress test/Holter monitor core lab analyses; brachial artery reactivity test core lab analyses; full study data analyses for manuscript preparation and the writing and submission and publication of manuscript.
The main trial duration: December 1999 - May 2003.
The ancillary data analysis project duration: April 2006 - March 2010.
详细描述
See Brief Summary above.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Hormone replacement therapy
Hormone replacement therapy with 1 mg norethindrone/10 mcg thinyl estradiol (1/10 NA/EE)
干预措施: 1/10 NA/EE (Drug)
Placebo
1mg placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Inducible Myocardial Ischemia
时间窗: 12 weeks
Inducible myocardial ischemia measured by P-31 gated magnetic resonance cardiac spectroscopy (MRS) is reported as change (∆) in PCr/ATP ratio, with isometric submaximal handgrip stress. PCr/ATP ratio defined as (stress-\[average of rest and recovery periods\]) / average of rest and recover periods X 100, and expressed as % mean ± SD. For this trial, myocardial ischemia was pre-specified as a fall in quantitative PCR/ATP ratio \>20% from rest, and a lower value is considered indicative of greater ischemia.
Endothelial Dysfunction (FMD)
时间窗: 12 weeks
Endothelial dysfunction refers to altered vasoactive, anticoagulant, and anti-inflammatory properties of endothelium, and dysregulated vascular growth remodeling that results from a loss of nitric oxide (NO) bioactivity in the endothelium. Brachial Artery Reactivity Testing (BART), high-frequency ultrasonographic imaging of the brachial artery, evaluates flow-mediated vasodilation (FMD), an endothelium-dependent function. The technique provokes the release of nitric oxide, resulting in vasodilation that can be quantitated as an index of vasomotor function. Flow-mediated vasodilation is typically expressed as the change in post-stimulus diameter as a percentage of the baseline diameter \[diameter after cuff deflation - baseline diameter / baseline diameter) x 100\].
次要结局
- Quality of Life - Menopause Symptoms(12 weeks)
- Quality of Life - Health Survey(12 weeks)
- Physical Functional Disability - Functional Capacity (Stress Induced ST Segment Depression)(Exit (12 weeks))
- Physical Functional Disability - Functional Capacity (METs)(Exit at 12 weeks)
- Physical Functional Disability - Functional Capacity (Metabolism Equivalents)(Exit (12 weeks))
- Physical Functional Disability - Functional Capacity (Exercise Induced ST Segment Depression)(Baseline)
研究者
Noel Bairey Merz
Director
Cedars-Sinai Medical Center