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临床试验/NCT05647876
NCT05647876
招募中
不适用

A Longitudinal Study to Identify Mechanisms of Menopause on Cardiovascular Disease Risk

University of Copenhagen1 个研究点 分布在 1 个国家目标入组 200 人2022年12月16日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Menopause
发起方
University of Copenhagen
入组人数
200
试验地点
1
主要终点
Invasive vascular function
状态
招募中
最后更新
2年前

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.

注册库
clinicaltrials.gov
开始日期
2022年12月16日
结束日期
2045年8月
最后更新
2年前
研究类型
Observational
性别
Female

研究者

责任方
Principal Investigator
主要研究者

Lasse Gliemann

Associate Professor

University of Copenhagen

入排标准

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)

研究点 (1)

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