A Longitudinal Study to Identify Mechanisms of Menopause on Cardiovascular Disease Risk
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Invasive vascular function
研究概览
简要总结
With the cessation of estrogen production at menopause, the risk of cardiovascular disease like arthrosclerosis, myocardial infarction and stroke increases dramatically. Physical activity is the single most powerful "drug" for maintaining and improving cardiovascular health, but recent data suggest that the positive effect of physical activity is lost at menopause. In this project the investigators will follow a cohort of 200 women from before the women enter menopause and until at least 10 years past menopause. By advanced invasive methodologies the investigators will monitor the changes that occur in the blood vessels of the circulation, the heart and the brain and combine this with microRNA sequencing of blood and tissue samples.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 61 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Normal ECG
- •Regular menstruation
排除标准
- •Participation in other clinical projects
- •Smokes or has smoked within the last 10 years
- •On hormone therapy
- •Has chronic diseases that are not expected, cf. the groups sought. Including heart problems, atrial fibrillation, cancer, immune diseases and previous strokes with functionally significant sequelae
- •Being treated with oral steroids
- •Has alcohol / drug abuse or is being treated with disulfiram (Antabus)
- •Is unable to understand the contents of the document with informed consent or the experimental procedures
- •Pregnancy or breastfeeding
- •Systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg
- •ovariectomy
结局指标
主要结局
Invasive vascular function
时间窗: pre, 1yr. 3yr. , 5 yr., 10 yr. and 20 yr. post menopause
Changes in vascular function across the menopausal transition (pre, 1yr. 3yr. , 5 yr., 10 yr. and 20 yr. post menopause Vascular function is assessed by intra-arterial infusions of acetylcholine and epoprostenol) in the brachial artery using ultrasound doppler
Non-invasive vascular function
时间窗: pre, 1yr. 3yr. , 5 yr., 10 yr. and 20 yr. post menopause
Changes in vascular function across the menopausal transition (pre, 1yr. 3yr. , 5 yr., 10 yr. and 20 yr. post menopause Vascular function is assessed by flow-mediated dilation (FMD) in the brachial artery using ultrasound doppler
次要结局
- Changes in skeletal muscle expression of protein(pre, 1yr. 3yr. , 5 yr., 10 yr. and 20 yr. post menopause)
- Changes in skeletal muscle and blood sample expression of RNA(pre, 1yr. 3yr. , 5 yr., 10 yr. and 20 yr. post menopause)
- Blood pressure(pre, 1yr. 3yr. , 5 yr., 10 yr. and 20 yr. post menopause)
研究者
Lasse Gliemann
Associate Professor
University of Copenhagen