NCT00005190

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jul 1986

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1986

Completed
12.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 1998

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

May 25, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 26, 2000

Completed
Last Updated

February 18, 2016

Status Verified

October 1, 2001

First QC Date

May 25, 2000

Last Update Submit

February 17, 2016

Conditions

Eligibility Criteria

AgeUp to 100 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
No eligibility criteria

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (6)

  • Morris CD, Outcalt J, Menashe VD. Hypoplastic left heart syndrome: natural history in a geographically defined population. Pediatrics. 1990 Jun;85(6):977-83.

    PMID: 2339046BACKGROUND
  • Morris CD, Magilke D, Reller M. Down's syndrome affects results of surgical correction of complete atrioventricular canal. Pediatr Cardiol. 1992 Apr;13(2):80-4. doi: 10.1007/BF00798209.

    PMID: 1535440BACKGROUND
  • Morris CD, Menashe VD. 25-year mortality after surgical repair of congenital heart defect in childhood. A population-based cohort study. JAMA. 1991 Dec 25;266(24):3447-52.

    PMID: 1744959BACKGROUND
  • Morris CD, Reller MD, Menashe VD. Thirty-year incidence of infective endocarditis after surgery for congenital heart defect. JAMA. 1998 Feb 25;279(8):599-603. doi: 10.1001/jama.279.8.599.

    PMID: 9486754BACKGROUND
  • Silka MJ, Hardy BG, Menashe VD, Morris CD. A population-based prospective evaluation of risk of sudden cardiac death after operation for common congenital heart defects. J Am Coll Cardiol. 1998 Jul;32(1):245-51. doi: 10.1016/s0735-1097(98)00187-9.

    PMID: 9669277BACKGROUND
  • Reller MD, Morris CD. Is Down syndrome a risk factor for poor outcome after repair of congenital heart defects? J Pediatr. 1998 Apr;132(4):738-41. doi: 10.1016/s0022-3476(98)70372-5.

    PMID: 9580782BACKGROUND

MeSH Terms

Conditions

Cardiovascular DiseasesHeart DiseasesHeart Defects, CongenitalAortic Valve StenosisTransposition of Great VesselsDuctus Arteriosus, PatentHeart Septal Defects, AtrialHeart Septal Defects, VentricularDown SyndromeTetralogy of FallotPulmonary Valve StenosisAortic Coarctation

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesAortic Valve DiseaseHeart Valve DiseasesVentricular Outflow ObstructionHeart Septal DefectsIntellectual DisabilityNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesAbnormalities, MultipleChromosome DisordersGenetic Diseases, Inborn

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

May 25, 2000

First Posted

May 26, 2000

Study Start

July 1, 1986

Study Completion

December 1, 1998

Last Updated

February 18, 2016

Record last verified: 2001-10