Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Myocardial Screening in Fetuses With Congenital Cytomegalovirus (CMV) Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02787382
Recruitment Status : Unknown
Verified May 2016 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : June 1, 2016
Last Update Posted : June 1, 2016
Sponsor:
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center

Tracking Information
First Submitted Date  ICMJE February 18, 2016
First Posted Date  ICMJE June 1, 2016
Last Update Posted Date June 1, 2016
Study Start Date  ICMJE June 2016
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 25, 2016)
  • diastolic strain RATE [ Time Frame: 5 month ]
    US test will measure diastolic strain RATE (will be measured by %)
  • systolic strain RATE [ Time Frame: 5 month ]
    US test will measure systolic strain RATE (will be measured by %)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Myocardial Screening in Fetuses With Congenital Cytomegalovirus (CMV) Infection
Official Title  ICMJE Myocardial Screening in Fetuses With Congenital Cytomegalovirus (CMV) Infection
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Disorder of Cardiac Function
Intervention  ICMJE 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.

Study Arms  ICMJE
  • 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).

    Intervention: Device: echocardiographic examination
  • 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.

    Intervention: Device: echocardiographic examination
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 25, 2016)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2019
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02787382
Other Study ID Numbers  ICMJE 0804-15-TLV
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Tel-Aviv Sourasky Medical Center
Study Sponsor  ICMJE Tel-Aviv Sourasky Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Livia kapusta, professor Tel Aviv Medical Center
PRS Account Tel-Aviv Sourasky Medical Center
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP