Coxsackie Virus in Pregnancy and Congenital Heart Disease

NCT03737006 | Completed

• 1 other identifier: 201602122
• Study Type: observational
• Target: 122
• Locations: 1 country
• Sites: 1

Brief Summary

Investigators would like to find out if a woman's exposure to Coxsackievirus has an effect or increase in incidence of babies being born with congenital heart disease(CHD)

Conditions

Congenital Heart Disease in Pregnancy

Outcome Measures

Primary Outcomes (2)

• Maternal prenatal and newborn Cox B viral strand identification

  Virus identification: Comparison to VP1 sequences available in GenBank will be used to identify the strain of CVB in the isolates.

  3 - 5years

• Maternal prenatal and newborn Cox B antibody levels

  Serum CVB antibody titers: Past or current CVB infection will be determined from titers (\>/= 1:80) collected from stool, serum and a nasal swab.

  3 - 5years

Secondary Outcomes (1)

• Variables and trends influencing Congenital Heart Disease

  3-5 years

Study Arms (3)

1-(HLHS) effected pregnancies

Consent,blood draw, nose swab, stool collection,questionnaire and review of medical records.

2-Other Congenital Heart Defect (OCHD)

Consent, blood draw, nose swab, stool collection, questionnaire and review of medical records.

3-Healthy Controls (UC)

Consent, blood draw, nose swab, stool collection, questionnaire and review of medical records.

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant Women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant Woman whose babies have been diagnosed with CHD ( a congenital heart defect) and controls (pregnant women babies without CHD).

You may qualify if:

• Fetal echocardiogram demonstrating one of the following: Hypoplastic Left Heart Syndrome (HLHS) or variant, other congenital heart disease (OCHD), or unaffected control (UC)
• Gestation is ≥20 wks-fetal group (HLHS, OCHD)
• Subject is able and willing to give informed consent.

You may not qualify if:

• Subject is \< 18 years of age.
• Subject is pregnant with twins or multiple gestations.
• Subject's pregnancy is affected by 3 or more congenital anomalies (in addition to the heart defect).
• Subject's pregnancy is affected by chromosomal anomalies (OCHD \& UC groups)
• Maternal history of chromosomal anomaly (OCHD \& UC groups)
• Infertility treatment for current/index pregnancy

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

St Louis Childrens Hospital

St Louis, Missouri, 63110, United States

Location

Related Publications (7)

• Tchervenkov CI, Jacobs JP, Weinberg PM, Aiello VD, Beland MJ, Colan SD, Elliott MJ, Franklin RC, Gaynor JW, Krogmann ON, Kurosawa H, Maruszewski B, Stellin G. The nomenclature, definition and classification of hypoplastic left heart syndrome. Cardiol Young. 2006 Aug;16(4):339-68. doi: 10.1017/S1047951106000291.

  PMID: 16839428 BACKGROUND

• Hickey EJ, Caldarone CA, McCrindle BW. Left ventricular hypoplasia: a spectrum of disease involving the left ventricular outflow tract, aortic valve, and aorta. J Am Coll Cardiol. 2012 Jan 3;59(1 Suppl):S43-54. doi: 10.1016/j.jacc.2011.04.046.

  PMID: 22192721 BACKGROUND

• Kallewaard NL, Zhang L, Chen JW, Guttenberg M, Sanchez MD, Bergelson JM. Tissue-specific deletion of the coxsackievirus and adenovirus receptor protects mice from virus-induced pancreatitis and myocarditis. Cell Host Microbe. 2009 Jul 23;6(1):91-8. doi: 10.1016/j.chom.2009.05.018.

  PMID: 19616768 BACKGROUND

• Shi Y, Chen C, Lisewski U, Wrackmeyer U, Radke M, Westermann D, Sauter M, Tschope C, Poller W, Klingel K, Gotthardt M. Cardiac deletion of the Coxsackievirus-adenovirus receptor abolishes Coxsackievirus B3 infection and prevents myocarditis in vivo. J Am Coll Cardiol. 2009 Apr 7;53(14):1219-26. doi: 10.1016/j.jacc.2008.10.064.

  PMID: 19341864 BACKGROUND

• Bergelson JM, Cunningham JA, Droguett G, Kurt-Jones EA, Krithivas A, Hong JS, Horwitz MS, Crowell RL, Finberg RW. Isolation of a common receptor for Coxsackie B viruses and adenoviruses 2 and 5. Science. 1997 Feb 28;275(5304):1320-3. doi: 10.1126/science.275.5304.1320.

  PMID: 9036860 BACKGROUND

• McBride KL, Marengo L, Canfield M, Langlois P, Fixler D, Belmont JW. Epidemiology of noncomplex left ventricular outflow tract obstruction malformations (aortic valve stenosis, coarctation of the aorta, hypoplastic left heart syndrome) in Texas, 1999-2001. Birth Defects Res A Clin Mol Teratol. 2005 Aug;73(8):555-61. doi: 10.1002/bdra.20169.

  PMID: 16007587 BACKGROUND

• Delorme-Axford E, Donker RB, Mouillet JF, Chu T, Bayer A, Ouyang Y, Wang T, Stolz DB, Sarkar SN, Morelli AE, Sadovsky Y, Coyne CB. Human placental trophoblasts confer viral resistance to recipient cells. Proc Natl Acad Sci U S A. 2013 Jul 16;110(29):12048-53. doi: 10.1073/pnas.1304718110. Epub 2013 Jul 1.

  PMID: 23818581 BACKGROUND

Study Officials

• Pirooz Eghtesady, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2017
• First Posted: November 9, 2018
• Study Start: March 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: August 4, 2022

Record last verified: 2022-08

Locations

US (1)