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

NCT01669057 | Completed DMC

• 1 other identifier: KY2011-366
• Study Type: observational
• Target: 6,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Heart Disease

Keywords

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

Outcome Measures

Primary Outcomes (2)

• genome-wide DNA SNPs and methylations

  DNA sample from neonate blood

  delivery

• perinatal supplements and drug using

  questionnaire including supplements and drug using for mother

  three months before pregnancy till delivery

Secondary Outcomes (4)

• Life risk factors of mother

  three months before pregnancy till delivery

• Life risk factors of father

  three months before pregnancy till delivery

• gestational weeks

  delivery

• birth weight

  delivery

Study Arms (2)

Congenital heart defect（CHD） group

Normal control group

Eligibility Criteria

• Age: Up to 3 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The population is from two ongoing projects- "Key Clinical Research Project Sponsored by Ministry of Health Screening, evaluation and intervention of congenital heart disease in newborn infants(2010-239)" and "Health and Public Welfare Research Project Sponsored by Ministry of Health of China Screening and evaluation of congenital heart disease in children of under 3 years old in the countryside(20102006)"

You may qualify if:

• Han ethnic
• \~3 years old
• screened by 7 indicator, diagnosed by ultrasound

You may not qualify if:

• with other brith defects
• with Patent Ductus Arteriosus (PDA) and Patent Foramen Ovale (PFO)
• Control group
• Han ethnic
• \~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
• With other birth defects

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead
• Ningbo Women & Children's Hospital: collaborator
• Changzhou Maternal and Child Care Hospital: collaborator
• Maternal and Child Health Hospital of Taian: collaborator
• Maternal and Child Health Hospital of Wuxi: collaborator
• Kunshan City Maternal and Child Health: collaborator
• The First Affiliated Hospital of Xiamen University: collaborator
• Maternal and Child Health Hospital, Jiading District: collaborator
• Minhang Maternal and Children Health Care Hospital: collaborator

Study Sites (1)

Children Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

whole blood

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor,President

Study Record Dates

• First Submitted: August 16, 2012
• First Posted: August 20, 2012
• Study Start: October 1, 2011
• Study Completion: August 1, 2014
• Last Updated: March 11, 2015

Record last verified: 2015-03

Locations

CN (1)