NCT01916499

Brief Summary

This study involves adolescents operated with arterial switch procedure for transposition of the great arteries during the neonatal period. The purpose is to evaluate the coronary arteries and direct and indirect findings of coronary artery disease/complications with 3 tesla magnetic resonance imaging.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 2, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 5, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

May 25, 2017

Status Verified

May 1, 2017

Enrollment Period

2.9 years

First QC Date

August 2, 2013

Last Update Submit

May 23, 2017

Conditions

Transposition of Great VesselsSurgery

Keywords

Child, adolescentCoronary artery diseaseMagnetic resonance imaging

Outcome Measures

Primary Outcomes (1)

  • Direct visualization and status of the coronary arteries, global volume measurements, global and regional strain (myocardial contractility), extravascular, extracellular tissue volume fraction and late enhancement (myocardial fibrosis).

    10-15 years after surgery

Secondary Outcomes (2)

  • Comparison of image quality of direct visualization of the coronary arteries with and without contrast enhanced techniques.

    10-15 years after surgery

  • Comparison of coronary artery findings corresponding to indirect functional and morphological findings in MRI and echocardiography in the left and right ventricle.

    10-15 years after surgery

Study Arms (2)

Switch "trap-door" re-implantation of the coronaries

Re-implantation of the coronary arteries into the neo-aortic sinuses through a "trap-door" as far distally as possible on the neo-aorta

Other: 3 tesla magnetic resonance imaging findings; coronary artery statusOther: 3 tesla magnetic resonance imaging findings; ventricular function and morphology

Switch non-"trap-door" re-implantation of the coronaries

Re-implantation of the coronary arteries into the neo-aortic sinuses through small incisions or excision in the sinuses

Other: 3 tesla magnetic resonance imaging findings; coronary artery statusOther: 3 tesla magnetic resonance imaging findings; ventricular function and morphology

Interventions

3 tesla magnetic resonance imaging findings; coronary artery statusOTHER
Switch "trap-door" re-implantation of the coronariesSwitch non-"trap-door" re-implantation of the coronaries
3 tesla magnetic resonance imaging findings; ventricular function and morphologyOTHER
Switch "trap-door" re-implantation of the coronariesSwitch non-"trap-door" re-implantation of the coronaries

Eligibility Criteria

Age10 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Patients 10-15 years old surgically corrected in the neonatal period with arterial switch procedure for transposition of the great arteries at Rikshospitalet, OUS, Norway.

You may qualify if:

  • Clinical diagnosis of transposition of the great arteries with or without ventricular septum defect
  • Surgically corrected during neonatal period with arterial switch procedure

You may not qualify if:

  • Heart arrhythmias
  • Known allergic reaction to gadolinium based contrast media
  • Reduced renal function (below 60 ml/min/1,73m2)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital, Rikshospitalet

Oslo, 0424, Norway

Location

MeSH Terms

Conditions

Transposition of Great VesselsCoronary Artery Disease

Interventions

Ventricular Function

Condition Hierarchy (Ancestors)

Heart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCoronary DiseaseMyocardial IschemiaArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Cardiovascular Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Officials

  • Charlotte De Lange, MD PhD

    Oslo University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 2, 2013

First Posted

August 5, 2013

Study Start

May 1, 2012

Primary Completion

April 1, 2015

Study Completion

January 1, 2017

Last Updated

May 25, 2017

Record last verified: 2017-05

Locations

NO(1)