Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005190
Status:
COMPLETED
Last Update Posted:
2016-02-18
First Post:
2000-05-25
Brief Title:
Reproduction and Survival After Cardiac Defect Repair
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:
2001-10
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 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
Detailed Description:
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
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
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
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 |
|---|---|---|---|
| R01HL039052 | NIH | None | httpsreporternihgovquickSearchR01HL039052 |