Myocardial Screening in Fetuses With Congenital Cytomegalovirus (CMV) Infection

Tel-Aviv Sourasky Medical Center100 enrolled

Overview

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 EXPECTED RESULTS Subtle myocardial deformation abnormalities are expected to be commonly found in fetuses and infants with CMV infection. CONCLUSIONS The findings of this present study will underscore the need for cardiac screening of fetuses and infants with congenital CMV infection, with long-term follow-up to document the natural history and disease burden of CMV in this population.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Interventions

echocardiographic examinationDEVICE

Patients will undergo echocardiography (us) 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 the healthy women from the group will serve as controls at the 2-7th day birth. Cardiac scans of fifty pregnant women and the healthy women from the group will serve as controls EXPECTED RESULTS Subtle myocardial deformation abnormalities are expected to be commonly found in fetuses and infants with CMV infection.

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients referred because of suspected CMV IUI as demonstrated by seroconversion during pregnancy or during the 3 months that precede LMP or 2. Patients referred because of suspected CMV IUI based on the presence borderline CMV serology 3. US signs indicative of intrauterine CMV infection (CNS and non CNS involvement). Exclusion Criteria: 1. Multifetal pregnancy. 2. Pregnant women planning to deliver elsewhere who are offered yet refuse to participate in the postnatal investigation following discharge from the hospital. 3. 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.

Outcomes

Primary Outcomes

diastolic strain RATE

US test will measure diastolic strain RATE (will be measured by %)

Time frame: 5 month

systolic strain RATE

US test will measure systolic strain RATE (will be measured by %)