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Study on Clinical Prognosis, Risk Factors and Genetic Basis of Congenital Heart Disease

Case-control Study on Environmental and Genetic Factors of Congenital Heart Disease

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01669057
Acronym
SCPRFGBCHD
Enrollment
6000
Registered
2012-08-20
Start date
2011-10-31
Completion date
2014-08-31
Last updated
2015-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Heart Disease

Keywords

Congenital heart disease, DNA variation, methylation, risk factors, supplements

Brief summary

The objective of this study is to investigate the effect of parental peri-natal environmental risk factors and genetic factors on the development of Congenital Heart Disease (CHD). Our hypothesis is that the distributions of some environmental and genetic risk factors significantly differ between neonates with and without CHD.

Detailed description

Congenital heart defect (CHD) is one of birth defects in the structure of the heart and/or great vessels. Many types of heart defects exist, most of which either obstruct blood flow in the heart or vessels near it, or cause blood to flow through the heart in an abnormal pattern. Heart defects are the leading cause of birth defect-related infant deaths. So far people recognize that the causes of CHD are the conjunct effect of environment and genetic factors, both of which remain unclear. The current stud aims at investigating all the possible perinatal parental environmental risk factors and underlying genetic factors to CHD, including DNA variation and methylations. A hospital-based 1:1 matched case control study is conducted. Subjects were recruited through neonatal screening program, which includes a clinical symptom screening followed by a cardiac ultrasound diagnosis for those with at least one clinical indicator. The blood sample of participant will be collected and the parents of subjects will be interviewed to completed a questionnaire including general information and possible risk factors to CHD.

Interventions

None listed

Sponsors

Ningbo Women & Children's Hospital
CollaboratorOTHER
Changzhou Maternal and Child Care Hospital
CollaboratorOTHER
Maternal and Child Health Hospital of Taian
CollaboratorUNKNOWN
Maternal and Child Health Hospital of Wuxi
CollaboratorUNKNOWN
Kunshan City Maternal and Child Health
CollaboratorOTHER
The First Affiliated Hospital of Xiamen University
CollaboratorOTHER
Maternal and Child Health Hospital, Jiading District
CollaboratorOTHER
Minhang Maternal and Children Health Care Hospital
CollaboratorOTHER
Children's Hospital of Fudan University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
No minimum to 3 Years
Healthy volunteers
Yes

Inclusion criteria

case group Inclusion Criteria: * Han ethnic * 0\ 3 years old * screened by 7 indicator, diagnosed by ultrasound

Exclusion criteria

* with other brith defects * with Patent Ductus Arteriosus (PDA) and Patent Foramen Ovale (PFO) Control group Inclusion Criteria: * Han ethnic * 0\ 3 years old * without any of 7 screen indicator , without CHD heart palpitations and other complaints about heart disease, born in the same hospital with cases

Design outcomes

Primary

MeasureTime frameDescription
genome-wide DNA SNPs and methylationsdeliveryDNA sample from neonate blood
perinatal supplements and drug usingthree months before pregnancy till deliveryquestionnaire including supplements and drug using for mother

Secondary

MeasureTime frameDescription
Life risk factors of motherthree months before pregnancy till deliverysmoking, drinking, health, family history
Life risk factors of fatherthree months before pregnancy till deliverysmoking, drinking, health, family history
gestational weeksdelivery
birth weightdelivery

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026