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Myocardial Screening in Fetuses With Congenital Cytomegalovirus (CMV) Infection

Primary Purpose

Disorder of Cardiac Function

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
echocardiographic examination
Sponsored by
Tel-Aviv Sourasky Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Disorder of Cardiac Function focused on measuring cytomegalovirus, TORCH, prenatal diagnosis, congenital infections, fetal abnormalities, echocardiography, myocardial deformation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Pregnant women with CMV infection

    Pregnant women with suspected CMV infection

    Arm Description

    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).

    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.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    February 18, 2016
    Last Updated
    May 25, 2016
    Sponsor
    Tel-Aviv Sourasky Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02787382
    Brief Title
    Myocardial Screening in Fetuses With Congenital Cytomegalovirus (CMV) Infection
    Official Title
    Myocardial Screening in Fetuses With Congenital Cytomegalovirus (CMV) Infection
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 2016 (undefined)
    Primary Completion Date
    June 2019 (Anticipated)
    Study Completion Date
    June 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Tel-Aviv Sourasky Medical Center

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Disorder of Cardiac Function
    Keywords
    cytomegalovirus, TORCH, prenatal diagnosis, congenital infections, fetal abnormalities, echocardiography, myocardial deformation

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Pregnant women with CMV infection
    Arm Type
    Experimental
    Arm Description
    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).
    Arm Title
    Pregnant women with suspected CMV infection
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    echocardiographic examination
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    diastolic strain RATE
    Description
    US test will measure diastolic strain RATE (will be measured by %)
    Time Frame
    5 month
    Title
    systolic strain RATE
    Description
    US test will measure systolic strain RATE (will be measured by %)
    Time Frame
    5 month

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 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). Exclusion Criteria: 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Livia kapusta, professor
    Phone
    052-4262564
    Email
    liviak@tlvmc.gov.il
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Livia kapusta, professor
    Organizational Affiliation
    Tel Aviv Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Myocardial Screening in Fetuses With Congenital Cytomegalovirus (CMV) Infection

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