Coxsackie Virus in Pregnancy and Congenital Heart Disease
NCT ID: NCT03737006
Last Updated: 2022-08-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
122 participants
OBSERVATIONAL
2016-03-01
2018-12-01
Brief Summary
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Detailed Description
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After informed consent participants will provide the following samples during one study visit: 10 mL (about 2 teaspoons) blood draw, a nose swab, provide a stool specimen (or have a rectal swab) and complete a study questionnaire Our 3 study groups are the following-Group 1 is Hypoplastic Left Heart Syndrome or HLHS effected pregnancies. Group 2 is OCHD- Other Congenital Heart Defects and Group 3 is Unaffected Controls (UC) also known as healthy controls.
After informed consent participants will provide the following samples: 10 mL (about 2 teaspoons) blood draw, a nose swab, provide a stool specimen (or have a rectal swab).
A health history review and questionnaire will also be obtained.
Analysis of these samples(blood, stool and nose secretions), a medical history review and questionnaire data will help to determine if there is a link or increased risk of those who may be exposed to virus.
Note- Prior to April 2016- the protocol and the healthy control (HC)subjects group were enrolled to come in for three study visits at varying times in their pregnancy. Blood, nose and stool samples were obtained at all three visits.
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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1-(HLHS) effected pregnancies
Consent,blood draw, nose swab, stool collection,questionnaire and review of medical records.
No interventions assigned to this group
2-Other Congenital Heart Defect (OCHD)
Consent, blood draw, nose swab, stool collection, questionnaire and review of medical records.
No interventions assigned to this group
3-Healthy Controls (UC)
Consent, blood draw, nose swab, stool collection, questionnaire and review of medical records.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Gestation is ≥20 wks-fetal group (HLHS, OCHD)
* Subject is able and willing to give informed consent.
Exclusion Criteria
* 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
18 Years
FEMALE
Yes
Sponsors
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Washington University School of Medicine
OTHER
Responsible Party
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Principal Investigators
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Pirooz Eghtesady, MD
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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St Louis Childrens Hospital
St Louis, Missouri, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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201602122
Identifier Type: -
Identifier Source: org_study_id
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