Ignite Creation Date:
2024-05-05 @ 9:57 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005258
Status:
COMPLETED
Last Update Posted:
2016-02-29
First Post:
2000-05-25
Brief Title:
Family Study of Congenital Cardiovascular Malformations
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2001-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To determine genetic mechanisms responsible for congenital cardiovascular malformations
Detailed Description:
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 109063 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
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
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 109063 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
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL044069 | NIH | None | httpsreporternihgovquickSearchR01HL044069 |