Myocardial Screening in Fetuses With Congenital Cytomegalovirus (CMV) Infection

NCT02787382 | Unknown Phase 3 DMC

• 1 other identifier: 0804-15-TLV
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Disorder of Cardiac Function

Keywords

cytomegalovirus; TORCH; prenatal diagnosis; congenital infections; fetal abnormalities; echocardiography; myocardial deformation

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Pregnant women with CMV infection

EXPERIMENTAL

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

Pregnant women with suspected CMV infection

EXPERIMENTAL

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

Interventions

echocardiographic examination DEVICE

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.

Pregnant women with CMV infection; Pregnant women with suspected CMV infection

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Officials

• Livia kapusta, professor

  Tel Aviv Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Livia kapusta, professor

CONTACT

052-4262564; liviak@tlvmc.gov.il

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2016
• First Posted: June 1, 2016
• Study Start: June 1, 2016
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: June 1, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share