Cardiovascular Disease After Preeclampsia
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 921
- 试验地点
- 3
- 主要终点
- Coronary atherosclerosis
研究概览
简要总结
Women with a history of preeclampsia (PE) have increased risk of hypertension and cardiovascular disease (CVD) later in life. Thus, PE is acknowledged as an independent risk factor for CVD, which is the number one cause of death in women in the western part of the world.
Objective:
The purpose of this study is to investigate 1) the prevalence of CVD after PE, 2) which women have the highest risk of developing CVD, 3) when early stages of CVD can be detected in women with previous PE and 4) how CVD progress over time.
Methods:
1000 women with previous PE between the age of 35-55 years will be invited to participate in a follow-up study consisting of anthropometric measurements, blood pressure measurement, urine- and blood samples, cardiac CT-scan and questionnaires. Coronary atherosclerosis will be evaluated using CT imaging.The women will be compared with women with a formerly uncomplicated pregnancy,
Summary:
The study will provide new important information to guide future clinical follow-up, and potentially prevent disease and early death in a large group of women with a history of PE.
详细描述
Women with a history of preeclampsia (PE) have increased risk of hypertension and cardiovascular disease (CVD) later in life. Thus, PE is acknowledged as an independent risk factor for CVD, which is the number one cause of death in women in the western part of the world. Despite this, solid and uniform guidelines regarding follow-up after a pregnancy complicated by PE are lacking. Little is known about the time-course of the development of CVD and how early stages can be identified in women with previous PE. The link between PE and CVD is well established. However, no large clinical study using cardiac CT-scans exists. Moreover, the study will focus on the time-perspective of the development of CVD in relation to index pregnancy, and this knowledge may prove to be essential to establish solid clinical guidelines addressing timely prevention and treatment.
The purpose of this study is to investigate
- The prevalence of CVD after PE,
- Which women have the highest risk of developing CVD
- When early stages of CVD can be detected in women with previous PE
- How CVD progress over time.
Thus, we hope to identify a window of opportunity where screening and preventive measures may be relevant and potentially beneficial to these women.
A total of 1000 women with previous PE (aged 35-55 years) will be invited to participate in a clinical follow-up study consisting of anthropometric measurements, blood pressure measurement, urine- and blood samples, cardiac CT-scan (identifying coronary atherosclerotic changes) and questionnaires. These women will be compared to age-matched women, without previous preeclampsia investigated in the Copenhagen General Population Study with an identical CT protocol.
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
- 35 Years 至 55 Years（Adult）
- 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
结局指标
主要结局
Coronary atherosclerosis
时间窗: Assessed within 30 days of study inclusion
Presensence of coronary plaque as defined by Cardiac CT
次要结局
- Presence of left bundle branch block(Assessed within 30 days of study inclusion)
- Dyspnoe(Assessed within 30 days of study inclusion)
- Presence of T-wave inversion(Assessed within 30 days of study inclusion)
- Presence of atrial fibrillation(Assessed within 30 days of study inclusion)
- Presence of left ventricular hypertrophy(Assessed within 30 days of study inclusion)
- Arterial hypertension(Assessed within 30 days of study inclusion)
- Chest pain(Assessed within 30 days of study inclusion)
研究者
Klaus Fuglsang Kofoed
Clinical Associated Research Professor
Rigshospitalet, Denmark