Ignite Creation Date:
2025-12-24 @ 6:57 PM
Ignite Modification Date:
2026-02-21 @ 11:18 PM
Study NCT ID:
NCT01669057
Status:
COMPLETED
Last Update Posted:
2015-03-11
First Post:
2012-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study on Clinical Prognosis, Risk Factors and Genetic Basis of Congenital Heart Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006330', 'term': 'Heart Defects, Congenital'}], 'ancestors': [{'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'whole blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 6000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-09', 'studyFirstSubmitDate': '2012-08-16', 'studyFirstSubmitQcDate': '2012-08-17', 'lastUpdatePostDateStruct': {'date': '2015-03-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'genome-wide DNA SNPs and methylations', 'timeFrame': 'delivery', 'description': 'DNA sample from neonate blood'}, {'measure': 'perinatal supplements and drug using', 'timeFrame': 'three months before pregnancy till delivery', 'description': 'questionnaire including supplements and drug using for mother'}], 'secondaryOutcomes': [{'measure': 'Life risk factors of mother', 'timeFrame': 'three months before pregnancy till delivery', 'description': 'smoking, drinking, health, family history'}, {'measure': 'Life risk factors of father', 'timeFrame': 'three months before pregnancy till delivery', 'description': 'smoking, drinking, health, family history'}, {'measure': 'gestational weeks', 'timeFrame': 'delivery'}, {'measure': 'birth weight', 'timeFrame': 'delivery'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Congenital heart disease', 'DNA variation', 'methylation', 'risk factors', 'supplements'], 'conditions': ['Congenital Heart Disease']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '3 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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)"', 'healthyVolunteers': True, 'eligibilityCriteria': 'case group\n\nInclusion Criteria:\n\n* Han ethnic\n* 0\\~3 years old\n* screened by 7 indicator, diagnosed by ultrasound\n\nExclusion Criteria:\n\n* with other brith defects\n* with Patent Ductus Arteriosus (PDA) and Patent Foramen Ovale (PFO)\n\nControl group\n\nInclusion Criteria:\n\n* Han ethnic\n* 0\\~3 years old\n* without any of 7 screen indicator , without CHD heart palpitations and other complaints about heart disease, born in the same hospital with cases\n\nExclusion Criteria:\n\nWith other birth defects'}, 'identificationModule': {'nctId': 'NCT01669057', 'acronym': 'SCPRFGBCHD', 'briefTitle': 'Study on Clinical Prognosis, Risk Factors and Genetic Basis of Congenital Heart Disease', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital of Fudan University"}, 'officialTitle': 'Case-control Study on Environmental and Genetic Factors of Congenital Heart Disease', 'orgStudyIdInfo': {'id': 'KY2011-366'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Congenital heart defect（CHD） group'}, {'label': 'Normal control group'}]}, 'contactsLocationsModule': {'locations': [{'zip': '201102', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Children Hospital of Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital of Fudan University", 'class': 'OTHER'}, 'collaborators': [{'name': "Ningbo Women & Children's Hospital", 'class': 'OTHER'}, {'name': 'Changzhou Maternal and Child Care Hospital', 'class': 'OTHER'}, {'name': 'Maternal and Child Health Hospital of Taian', 'class': 'UNKNOWN'}, {'name': 'Maternal and Child Health Hospital of Wuxi', 'class': 'UNKNOWN'}, {'name': 'Kunshan City Maternal and Child Health', 'class': 'OTHER'}, {'name': 'The First Affiliated Hospital of Xiamen University', 'class': 'OTHER'}, {'name': 'Maternal and Child Health Hospital, Jiading District', 'class': 'OTHER'}, {'name': 'Minhang Maternal and Children Health Care Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor,President', 'investigatorFullName': 'Guoying huang', 'investigatorAffiliation': "Children's Hospital of Fudan University"}}}}