MRI Study After Arterial Switch Operation in Patients With Transposition of the Great Arteries

NCT ID: NCT01916499

Last Updated: 2017-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-05-31

Study Completion Date

2017-01-31

Brief Summary

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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.

Detailed Description

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This study involves adolescents operated with arterial switch procedure for transposition of the great arteries during the neonatal period. The patients were operated with two different methods of re-implantation of the coronary arteries ("trap-door"/non-"trap-door", see description below).

Conditions

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Transposition of Great Vessels Surgery

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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

3 tesla magnetic resonance imaging findings; coronary artery status

Intervention Type OTHER

3 tesla magnetic resonance imaging findings; ventricular function and morphology

Intervention Type OTHER

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

3 tesla magnetic resonance imaging findings; coronary artery status

Intervention Type OTHER

3 tesla magnetic resonance imaging findings; ventricular function and morphology

Intervention Type OTHER

Interventions

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3 tesla magnetic resonance imaging findings; coronary artery status

Intervention Type OTHER

3 tesla magnetic resonance imaging findings; ventricular function and morphology

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

10 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Kathrine Rydén Suther

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Charlotte De Lange, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Locations

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Oslo University Hospital, Rikshospitalet

Oslo, , Norway

Site Status

Countries

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Norway

Other Identifiers

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2011/1422

Identifier Type: -

Identifier Source: org_study_id

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