Etiologic Risk Factors of Cardiovascular Malformations

February 26, 2016 updated by: National Heart, Lung, and Blood Institute (NHLBI)
To identify genetic and environmental risk factors for congenital cardiac disease.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 100 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

No eligibility criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Publications and helpful links

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General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 1980

Study Completion (Actual)

November 1, 1998

Study Registration Dates

First Submitted

May 25, 2000

First Submitted That Met QC Criteria

May 25, 2000

First Posted (Estimate)

May 26, 2000

Study Record Updates

Last Update Posted (Estimate)

February 29, 2016

Last Update Submitted That Met QC Criteria

February 26, 2016

Last Verified

October 1, 2001

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1025
  • R37HL025629 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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