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Sponsored by: |
National Heart, Lung, and Blood Institute (NHLBI) |
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Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
ClinicalTrials.gov Identifier: | NCT00005258 |
To determine genetic mechanisms responsible for congenital cardiovascular malformations.
Condition |
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Cardiovascular Diseases Defect, Congenital Heart Heart Diseases |
Study Type: | Observational |
Study Design: | Natural History |
Study Start Date: | June 1990 |
Estimated Study Completion Date: | May 1993 |
BACKGROUND:
Congenital cardiovascular malformations are a major cause of infant mortality in the United States. In 1985, six defects -- hypoplastic left heart, tetralogy of Fallot, truncus arteriosus, transposition of the great arteries, endocardial cushion defect, and ventricular septal defect -- were among the fifteen most frequent causes of premature death due to congenital malformations, accounting for 109,063 years of life lost. This loss of productive life continues in spite of major advances in medical and surgical treatment of congenital cardiovascular malformations. Even as successful treatment modalities are developed, the survival to reproductive years without improved understanding of genetic risks produces additional unanswered questions.
DESIGN NARRATIVE:
Clinical assessment of cases and controls included medical history, pedigree construction, complete evaluation by a pediatric cardiologist, and two-dimensional and Doppler echocardiography. First degree relatives of cases and controls underwent clinical-echocardiographic evaluation also. The distribution of cardiac defects for all pedigrees within and among the proband group was delineated. The frequencies of heart defects were compared within and among pedigrees of cases and controls. Regressive logistic models of genetic determinants for the malformations were tested. The three participating clinical centers included University of Maryland at Baltimore, the Johns Hopkins Hospital, and the University of Rochester in Rochester, New York.
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
No eligibility criteria
Study ID Numbers: | 1141 |
Study First Received: | May 25, 2000 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00005258 History of Changes |
Health Authority: | United States: Federal Government |
Heart Diseases Congenital Cardiovascular Malformations Cardiovascular Abnormalities Congenital Abnormalities Heart Defects, Congenital |
Heart Diseases Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Heart Defects, Congenital |