Myocardial Screening in Fetuses With Congenital Cytomegalovirus (CMV) Infection

• ClinicalTrials.gov Identifier: NCT02787382
• Recruitment Status: Unknown
• First Posted: June 1, 2016
• Last Update Posted: June 1, 2016
• Sponsor: Tel-Aviv Sourasky Medical Center
• Information provided by (Responsible Party): Tel-Aviv Sourasky Medical Center

Tracking Information

• First Submitted Date: February 18, 2016
• First Posted Date: June 1, 2016
• Last Update Posted Date: June 1, 2016
• Study Start Date: June 2016
• Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Myocardial Screening in Fetuses With Congenital Cytomegalovirus (CMV) Infection
• Official Title: 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic
• Condition: Disorder of Cardiac Function

Intervention

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

• 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

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: May 25, 2016): 100
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 2019
• Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT02787382
• Other Study ID Numbers: 0804-15-TLV
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Tel-Aviv Sourasky Medical Center
• Study Sponsor: Tel-Aviv Sourasky Medical Center
• Collaborators: Not Provided

Investigators

• Principal Investigator: Livia kapusta, professor; Tel Aviv Medical Center

• PRS Account: Tel-Aviv Sourasky Medical Center
• Verification Date: May 2016