Age at Menopause and Severity of Coronary Artery Disease Among Postmenopausal Women With Acute Coronary Syndromes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 675
- 试验地点
- 1
- 主要终点
- Extent of coronary artery disease at angio corelab (Gensini and SYNTAX score)
研究概览
简要总结
The Ladies ACS study will investigate the relation between age at menopause and severity of coronary artery disease in menopausal women with acute coronary syndromes and clinical indication to coronary angiography.
详细描述
Multicenter prospective study in consecutive patients hospitalized with a wide spectrum of ACS and clinical indication to coronary angiography.
Consecutive patients older than 55 years with an ACS undergoing coronary angiography are eligible for the study, irrespective of subsequent revascularization. Eligible are women and men with a 2:1 enrolment ratio.
Patients will be stratified according to gender and age, including four age categories: 55-64, 65-74, 75-85 and >85 years. Each age category will include 200 patients, and enrolment in each category will be stopped once this number has been reached.
A specific electronic web-based CRF will collect clinical and procedural data. Clinical data input will take place at the participating Centers. Angiographic data input will be performed at rthe angiographic corelab, blinded of clinical data.
The e-CRF will collect data on
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients >55 years of age with all of the following characteristics:
- •symptoms suggestive of acute myocardial ischemia within the previous 48 hours.
- •The diagnosis of an ACS must be confirmed by a typical rise and fall in serum troponin levels as defined by the Third Universal Definition of Myocardial Infarction.
- •ECG signs of myocardial ischemia defined as either transient or persistent ST segment elevation or depression >0.5 mm (but >1 mm in the case of ST-segment elevation), or persistent and definite T-wave inversion >1 mm, including the pseudonormalization of a previously negative T-wave, in ≥2 contiguous leads.
排除标准
- 未提供
结局指标
主要结局
Extent of coronary artery disease at angio corelab (Gensini and SYNTAX score)
时间窗: 1 day
The primary study end-point will be the severity of coronary artery disease, as appraised by the Gensini score
次要结局
未报告次要终点