NCT03313063已完成不适用
Myocardial Characterization With Magnetic Resonance Imaging in Patients After Preeclampsia (Pilot Study)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- any structural or functional change of the heart (combined outcome)
研究概览
简要总结
Preeclampsia is a systemic pregnancy disorder and is associated with an increased cardiovascular risk later in life. This study will characterize myocardial tissue in patients after preeclampsia compared to controls and investigate potential functional and structural changes in the heart of preeclamptic women primarily with two methods: cardiovascular magnetic resonance imaging and echocardiography. A comparison between these two methods, where appropriate, is also envisaged.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •postpartal window: 0.5 - 20 years
- •cases: diagnosis of preeclampsia during the index pregnancy
- •controls: age and BMI matched
排除标准
- •metal implants
- •kidney insufficiency (GFR < 30 ml/min/)
- •claustrophobia
- •contrast medium allergy
- •current pregnancy/ lactation
- •chronic hypertension (> 140/90)
- •diagnosis of previous cardiovascular disease
- •body weight over 120 kg
- •big tattoos in thorax area
结局指标
主要结局
any structural or functional change of the heart (combined outcome)
时间窗: 0.5 - 20 years after delivery
Combined outcome: myocardial fibrosis, edema, fat infiltrates, inflammation, reduced ejection fraction, hypertrophy
次要结局
- myocardial fat infiltrates(0.5 - 20 years after delivery)
- myocardial inflammation(0.5 - 20 years after delivery)
- myocardial hypertrophy(0.5 - 20 years after delivery)
- reduced ejection fraction(0.5 - 20 years after delivery)
- myocardial fibrosis(0.5 - 20 years after delivery)
- myocardial edema(0.5 - 20 years after delivery)
研究者
Florian Herse
PhD
Charite University, Berlin, Germany
研究点 (1)
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