Etiologic Risk Factors of Cardiovascular Malformations
Primary Purpose
Cardiovascular Diseases, Heart Diseases, Defect, Congenital Heart
Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Cardiovascular Diseases
Eligibility Criteria
No eligibility criteria
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00005153
First Posted
May 25, 2000
Last Updated
February 26, 2016
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00005153
Brief Title
Etiologic Risk Factors of Cardiovascular Malformations
Study Type
Observational
2. Study Status
Record Verification Date
October 2001
Overall Recruitment Status
Completed
Study Start Date
December 1980 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 1998 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
5. Study Description
Brief Summary
To identify genetic and environmental risk factors for congenital cardiac disease.
Detailed Description
BACKGROUND:
Congenital heart disease represents a major segment of clinically significant birth defects and is associated with high mortality and morbidity in infancy, a childhood marred with physical limitations and repeated invasive procedures, and an adulthood with increased risk of medical and social problems. Previous research has been principally directed to clinical methods of diagnosis and treatment, but the need for prediction and prenatal counseling requires further knowledge of environmental and familial risk factors. Congenital heart disease is not one of the malformations monitored by the International Clearing House of Birth Defects Surveillance System. Surveillance which does include congenital heart disease may lack diagnostic accuracy among the various reporting sources. Accurate clinical studies lack comparative control information. As a result, the true epidemiologic features of cardiac defects remain obscure.
DESIGN NARRATIVE:
The design of the Baltimore-Washington Infant Study was that of a case-control study. All infants under one year of age with confirmed diagnoses of congenital heart disease were eligible for inclusion if they were residents of the study area which encompassed 53 area hospitals in Maryland, the District of Columbia and five counties in Virginia. Case enrollment was done through five pediatric cardiology centers and through a periodic search of the obstetrics and neonatal and pathology logs of the participating hospitals. Control selection was by random numbers and all resident births were eligible as controls except for those with congenital heart disease. Mothers of cases and controls were interviewed at home for demographic information, and information on maternal health, maternal medication, reproductive history, lifestyle, environmental exposures in the home, occupation, and agents transmitted to the mother by the father. Data were collected on the characteristics, drug use, habits, and occupations of the fathers. Vital records and birth certificates were abstracted for all cases and controls. Death certificates were also abstracted. Variables including drugs, lifestyle and home exposures, and occupation, were screened to identify which single factors were most importantly related to congenital heart disease.
Cases in which congenital heart disease was part of a genetic complex were evaluated separately for environmental exposures. Genetic data analysis focused on first degree relatives but extended family data were noted wherever available. The genetic data analyses included: estimation of recurrence risks in siblings for congenital heart disease with the same cardiac defect; any cardiac defect in the sibling; non cardiac birth defect and pregnancy loss in the family. Parental phenotype was investigated for the presence of birth defects and known genetic disorders. Twin births were assessed for concordance in zygosity. Hypotheses of genetic and environmental teratogenic and coteratogenic interactions were tested. Pathogenic mechanisms were further defined through anatomic and echocardiographic observations. The family inquiry was expanded to include cousins. Nutrition information was added on maternal vitamin A supplementation, protein, calories, and other nutrients.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Heart Diseases, Defect, Congenital Heart
7. Study Design
10. Eligibility
Sex
Male
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
No eligibility criteria
12. IPD Sharing Statement
Citations:
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Etiologic Risk Factors of Cardiovascular Malformations
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