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

Congenital Heart Disease Clinical Trial

— SCPRFGBCHD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01669057
• Other study ID #: KY2011-366
• Status: Completed
• Phase: N/A
• First received: August 16, 2012
• Last updated: March 9, 2015
• Start date: October 2011
• Est. completion date: August 2014

Study information

• Verified date: March 2015
• Source: Children's Hospital of Fudan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6000
• Est. completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 3 Years

Eligibility

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

Exclusion Criteria:

With other birth defects

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases

Locations

Country	Name	City	State
China	Children Hospital of Fudan University	Shanghai	Shanghai

Sponsors (9)

Lead Sponsor	Collaborator
Children's Hospital of Fudan University	Changzhou Maternal and Child Care Hospital, Kunshan City Maternal and Child Health, Maternal and Child Health Hospital of Taian, Maternal and Child Health Hospital of Wuxi, Maternal and Child Health Hospital, Jiading District, Minhang Maternal and Children Health Care Hospital, Ningbo women's children's hospital, The First Affiliated Hospital of Xiamen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	genome-wide DNA SNPs and methylations	DNA sample from neonate blood	delivery	No
Primary	perinatal supplements and drug using	questionnaire including supplements and drug using for mother	three months before pregnancy till delivery	No
Secondary	Life risk factors of mother	smoking, drinking, health, family history	three months before pregnancy till delivery	No
Secondary	Life risk factors of father	smoking, drinking, health, family history	three months before pregnancy till delivery	No
Secondary	gestational weeks		delivery	No
Secondary	birth weight		delivery	No