Terminé

Reproduction and Survival After Cardiac Defect Repair

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Ce qui est collecté

Collecte de données

Qui peut participer

Anomalies Congénitales+23

+ Anomalies, Multiples

+ Maladie de la valve aortique

Jusqu'à 100 ans
Voir tous les critères d'éligibilité
Comment se déroule l'étude

Observationnel
Date de début : juillet 1986
Voir le détail du protocole

Résumé

Sponsor principalNational Heart, Lung, and Blood Institute (NHLBI)
Dernière mise à jour : 18 février 2016
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Date de début de l'étude : 1 juillet 1986

Date à laquelle le premier participant a commencé l'étude.

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.

NCT00005190
Sponsor principalNational Heart, Lung, and Blood Institute (NHLBI)
Dernière mise à jour : 18 février 2016
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Protocole

Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.

Éligibilité

Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.
Conditions
Critères

Homme

Le sexe biologique des participants éligibles à s'inscrire.

Jusqu'à 100 ans

Tranche d'âge des participants éligibles à participer.

Volontaires sains non autorisés

Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.

Conditions

Pathologie

Anomalies CongénitalesAnomalies, MultiplesMaladie de la valve aortiqueDéfauts septaux du cœurMaladies des Valves CardiaquesDéficience IntellectuelleMaladies et anomalies congénitales, héréditaires et néonatalesMaladies du système nerveuxManifestations NeurologiquesObstruction de la Sortie VentriculaireAnomalies cardiovasculairesManifestations NeurocomportementalesTroubles ChromosomiquesMaladies Génétiques CongénitalesCoarctation aortiqueSténose de la valve aortiqueMaladies CardiovasculairesTrisomie 21Canal artériel perméableMalformations Congénitales du CœurMaladies CardiaquesDéfauts du septum auriculaireDéfauts du septum cardiaque, ventriculaireSténose de la valve pulmonaireTétralogie de FallotTransposition des gros vaisseaux

Critères

No eligibility criteria

Centres d'étude

Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.
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TerminéAucun centre d'étude