Pregnancy Outcomes in Patients With Adult Congenital Heart Disease
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- Mayo Clinic
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Number of Subjects with cardiovascular adverse events
研究概览
简要总结
The purpose of this study is to determine if a biomarker assay obtained peripartum (1st-3rd trimester and post-partum) in patients with adult congenital heart disease can predict future risk of cardiovascular adverse events and determine if temporal changes in biomarkers levels throughout the peripartum period can provide a better risk prediction compared to samples taken at a single time-point.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Congenital Heart Disease Diagnosis
- •Currently Pregnant
排除标准
- •Unable to consent
结局指标
主要结局
Number of Subjects with cardiovascular adverse events
时间窗: Baseline
A cardiovascular adverse event is defined as Documented atrial/ventricular arrhythmias, need for cardioversion, arrhythmia-related procedures (catheter ablation, implantation of pacemaker/defibrillator, anti-arrhythmia surgery), and heart failure hospitalization.
次要结局
- Number of Subject Deaths(Baseline)
研究者
Alexander C. Egbe
Principal Investigator
Mayo Clinic