Myocardial Screening in Fetuses With Congenital Cytomegalovirus (CMV) Infection
试验速览
- 阶段
- 3 期
- 入组人数
- 100
- 主要终点
- diastolic strain RATE
研究概览
简要总结
BACKGROUND
Myocarditis and pericarditis are inflammatory conditions of the heart commonly due to viral or autoimmune etiologies. Human CMV represents one of the leading causes of congenital infections worldwide. There is limited data regarding the cardiac function of fetuses and infants with CMV.
OBJECTIVE
To provide insight regarding the presence of myocardial involvement in fetuses and infants with CMV infection.
PATIENTS & METHODS
Up to 100 fetuses with suspected CMV infection will be enrolled during a 3 years period. Patients will undergo detailed US examinations including dedicated neurosonography and echocardiography starting at the time of the first referral and every 3-4 weeks until delivery and at the 2-7th day birth. Cardiac scans of fifty pregnant women and the healthy women from the group will serve as controls
详细描述
BACKGROUND
Myocarditis and pericarditis are inflammatory conditions of the heart commonly due to viral or autoimmune etiologies. Human CMV represents one of the leading causes of congenital infections worldwide. There is limited data regarding the cardiac function of fetuses and infants with CMV.
OBJECTIVE
To provide insight regarding the presence of myocardial involvement in fetuses and infants with CMV infection.
PATIENTS & METHODS
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients referred because of suspected CMV IUI as demonstrated by seroconversion during pregnancy or during the 3 months that precede LMP or
- •Patients referred because of suspected CMV IUI based on the presence borderline CMV serology
- •US signs indicative of intrauterine CMV infection (CNS and non CNS involvement).
排除标准
- •Multifetal pregnancy.
- •Pregnant women planning to deliver elsewhere who are offered yet refuse to participate in the postnatal investigation following discharge from the hospital.
- •Patients will be excluded if they had clinical heart failure, as defined by the New York Heart Association classification (NYHA, class II-IV) (Criteria committee of NYHA 1994), a history of cardiovascular disease or chronic renal insufficiency.
结局指标
主要结局
diastolic strain RATE
时间窗: 5 month
US test will measure diastolic strain RATE (will be measured by %)
systolic strain RATE
时间窗: 5 month
US test will measure systolic strain RATE (will be measured by %)
次要结局
未报告次要终点