Myocardial Screening in Fetuses With Congenital Cytomegalovirus (CMV) Infection

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

Study Overview

• Status: Unknown
• Conditions: Disorder of Cardiac Function
• Intervention / Treatment: Device: echocardiographic examination

Detailed Description

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
• Enrollment (Anticipated): 100
• Phase: Phase 3

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pregnant women with CMV infection; An attempt to record the fetal myocardium will be done at the initial examination and at all the follow up examinations performed during pregnancy (every 3-4 weeks according to the clinical protocol currently in use at the OB-GYN US Unit). The participants will undergo a detailed fetal echocardiography according to standard guidelines (see below, section echocardiography).	Device: echocardiographic examination; 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.
Experimental: Pregnant women with suspected CMV infection; The healthy women from the group will serve as controls. An attempt to record the fetal myocardium will be done at the initial examination and at all the follow up examinations performed during pregnancy (every 3-4 weeks according to the clinical protocol currently in use at the OB-GYN US Unit). The participants will undergo a detailed fetal echocardiography according to standard guidelines (see below, section echocardiography). As the control group-Newborns found to be negative for CMV will serve as control group.	Device: echocardiographic examination; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
diastolic strain RATE	US test will measure diastolic strain RATE (will be measured by %)	5 month
systolic strain RATE	US test will measure systolic strain RATE (will be measured by %)	5 month

Collaborators and Investigators

• Sponsor: Tel-Aviv Sourasky Medical Center
• Investigators: Principal Investigator: Livia kapusta, professor, Tel Aviv Medical Center

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Anticipated): June 1, 2019
• Study Completion (Anticipated): June 1, 2019

Study Registration Dates

• First Submitted: February 18, 2016
• First Submitted That Met QC Criteria: May 25, 2016
• First Posted (Estimate): June 1, 2016

Study Record Updates

• Last Update Posted (Estimate): June 1, 2016
• Last Update Submitted That Met QC Criteria: May 25, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: echocardiography; cytomegalovirus; prenatal diagnosis; TORCH; congenital infections; fetal abnormalities; myocardial deformation
• Additional Relevant MeSH Terms: Virus Diseases; DNA Virus Infections; Herpesviridae Infections; Infections; Cytomegalovirus Infections
• Other Study ID Numbers: 0804-15-TLV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No