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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Fudan University.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Ningbo women's children's hospital
Changzhou Maternal and Child Care Hospital
Maternal and Child Health Hospital of Taian
Maternal and Child Health Hospital of Wuxi
Kunshan City Maternal and Child Health
The First Affiliated Hospital of Xiamen University
Maternal and Child Health Hospital, Jiading District
Minhang Maternal and Children Health Care Hospital
Information provided by (Responsible Party):
Guoying huang, Children's Hospital of Fudan University
ClinicalTrials.gov Identifier:
NCT01669057
First received: August 16, 2012
Last updated: August 17, 2012
Last verified: August 2012
  Purpose

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.


Condition
Congenital Heart Disease

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Case-control Study on Environmental and Genetic Factors of Congenital Heart Disease

Resource links provided by NLM:


Further study details as provided by Fudan University:

Primary Outcome Measures:
  • genome-wide DNA SNPs and methylations [ Time Frame: delivery ] [ Designated as safety issue: No ]
    DNA sample from neonate blood

  • perinatal supplements and drug using [ Time Frame: three months before pregnancy till delivery ] [ Designated as safety issue: No ]
    questionnaire including supplements and drug using for mother


Secondary Outcome Measures:
  • Life risk factors of mother [ Time Frame: three months before pregnancy till delivery ] [ Designated as safety issue: No ]
    smoking, drinking, health, family history

  • Life risk factors of father [ Time Frame: three months before pregnancy till delivery ] [ Designated as safety issue: No ]
    smoking, drinking, health, family history

  • gestational weeks [ Time Frame: delivery ] [ Designated as safety issue: No ]
  • birth weight [ Time Frame: delivery ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

whole blood


Estimated Enrollment: 6000
Study Start Date: October 2011
Groups/Cohorts
Congenital heart defect(CHD) group
Normal control group

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.

  Eligibility

Ages Eligible for Study:   up to 3 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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)"

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

Exclusion Criteria:

With other birth defects

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01669057

Locations
China, Shanghai
Children Hospital of Fudan University Recruiting
Shanghai, Shanghai, China, 201102
Contact: Weili Yan, PhD    (86) 21 64931215    01.weili@gmail.com   
Sponsors and Collaborators
Fudan University
Ningbo women's children's hospital
Changzhou Maternal and Child Care Hospital
Maternal and Child Health Hospital of Taian
Maternal and Child Health Hospital of Wuxi
Kunshan City Maternal and Child Health
The First Affiliated Hospital of Xiamen University
Maternal and Child Health Hospital, Jiading District
Minhang Maternal and Children Health Care Hospital
  More Information

No publications provided

Responsible Party: Guoying huang, Professor,President, Children's Hospital of Fudan University
ClinicalTrials.gov Identifier: NCT01669057     History of Changes
Other Study ID Numbers: KY2011-366
Study First Received: August 16, 2012
Last Updated: August 17, 2012
Health Authority: China: Ministry of Health

Keywords provided by Fudan University:
Congenital heart disease
DNA variation
methylation
risk factors
supplements

Additional relevant MeSH terms:
Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities

ClinicalTrials.gov processed this record on September 30, 2014