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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: | NCT00005190 |
To create a registry of all Oregon children undergoing surgical repair of congenital heart disease since 1958 in order to determine mortality, morbidity, and disability after surgery and to assess the safety of pregnancy in women with corrected congenital heart disease and the risk of prematurity and occurrence of congenital heart defects in offspring.
Condition |
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Cardiovascular Diseases Heart Diseases Defect, Congenital Heart Aortic Valve Stenosis Transposition of Great Vessels Ductus Arteriosus, Patent Heart Septal Defects, Atrial Heart Septal Defects, Ventricular Down Syndrome Tetralogy of Fallot Pulmonic Stenosis Coarctation of Aorta |
Study Type: | Observational |
Study Design: | Natural History |
Study Start Date: | July 1986 |
Estimated Study Completion Date: | December 1998 |
BACKGROUND:
Since 1960, surgical advances have led to correction of congenital heart defects in children who otherwise may not have achieved maturity.
Consequently, it became increasingly important to understand the long-term morbidity, mortality and functional status of these patients. Because of the tremendous outlay of time, money and personnel devoted to prolonging the lives of children with congenital heart defects, it was vital to examine the accomplishment of long-term goals: achievement of a normal lifespan as a functioning, effective member of society.
DESIGN NARRATIVE:
Preoperative, operative, and postoperative data for each patient were entered into the registry data base at chart review. Follow-up for each patient was gathered by mail questionnaire, telephone survey, and the National Death Index. Questionnaires assessed morbidity, functional status, and reproduction. Pregnancy and major events were confirmed from physicians' records. Follow-up for tetralogy of Fallot, ventricular septal defect, and atrial septal defect was conducted in years 1, 3, and 5, and for transposition of the great arteries, aortic stenosis, pulmonic stenosis, patent ductus arteriosus, and coarctation of the aorta in years 2 and 4. Chart review was completed in year 2 and cases were then identified prospectively.
Actuarial analysis and Cox proportional hazards models determined mortality, major morbidity, and their risk factors. Reproductive data were analyzed per years of fertility for the cohort, and compared to Oregon population statistics. During 1988-1989, chart review and data abstraction were completed for children having surgical corrections from 1958-1987 for the eight defects under study. Also, during 1988-1989, children undergoing cardiac surgery for the eight defects were added to the registry.
The study was renewed in 1993 to sustain and expand the registry of all Oregon children 18 years of age or younger undergoing surgical repair from 1958 to the present of 14 major congenital heart defects: tetralogy of Fallot (TOF), ventricular septal defect (VSD), atrial septal defect (ASD), coarctation of the aorta, pulmonic stenosis (PS), aortic stenosis (AS), transposition of the great arteries, patent ductus arteriosus (PDA), tricuspid atresia (TA), total anomalous pulmonary venous return (TAPVR), pulmonary atresia with intact ventricular septum (PA), PA with VSD, partial atrioventricular canal (AVC), and complete AVC. The first eight defects were included in the registry: TOF (n =438). VSD (n =402), ASD (n =496), COA (n =479), AS (n = 175), PS (n = 200), TGA (n = 169), and PDA (n = 533). All cases of surgical treatment of TA, TAPVR, PA, PA with VSD, and partial and complete AVC from 1958 to the present were added to the registry. Preoperative, operative, and postoperative data for each patient were entered into the database from chart review. Each hospital was visited twice yearly to ascertain new cases. Individuals were followed every two years for intercurrent events by mailed questionnaire or phone interview. Questionnaires and interviews assessed major morbidity, functional status, and reproduction. Pregnancy, major events, and recurrent CHD were confirmed by medical records. Actuarial analysis and the Cox proportional hazards model determined mortality, morbidity, and their risk factors, and compared observed survival with expected population survival. Reproductive data were analyzed per years of fertility for cohort, and compared to Oregon population statistics.
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
No eligibility criteria
Study ID Numbers: | 1068 |
Study First Received: | May 25, 2000 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00005190 History of Changes |
Health Authority: | United States: Federal Government |
Pathological Conditions, Anatomical Great Vessels Transposition Pulmonic Stenosis Constriction, Pathologic Heart Septal Defects, Atrial Heart Septal Defects, Ventricular Abnormalities, Multiple Congenital Abnormalities Aortic Valve Stenosis Neurobehavioral Manifestations Ductus Arteriosus, Patent Heart Septal Defects Heart Diseases Cardiovascular Abnormalities |
Chromosome Disorders Aortic Coarctation Fallot Tetralogy Heart Valve Diseases Mental Retardation Transposition of Great Vessels Genetic Diseases, Inborn Tetralogy of Fallot Neurologic Manifestations Ventricular Septal Defects Down Syndrome Congenital Heart Septum Defect Heart Defects, Congenital Transposition of Great Arteries |
Pathological Conditions, Anatomical Constriction, Pathologic Heart Septal Defects, Atrial Pathologic Processes Syndrome Heart Septal Defects, Ventricular Abnormalities, Multiple Cardiovascular Diseases Aortic Valve Stenosis Congenital Abnormalities Neurobehavioral Manifestations Ductus Arteriosus, Patent Heart Septal Defects Disease |
Heart Diseases Cardiovascular Abnormalities Nervous System Diseases Chromosome Disorders Aortic Coarctation Heart Valve Diseases Mental Retardation Genetic Diseases, Inborn Transposition of Great Vessels Tetralogy of Fallot Neurologic Manifestations Down Syndrome Heart Defects, Congenital Ventricular Outflow Obstruction |