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

University of Oslo (UIO)

Status: Completed

Conditions: Surgery; Transposition of Great Vessels

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

Study type: Observational

Funder types: Other

Identifiers

NCT01916499

2011/1422

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 70 patients

Sex: All

Ages: 10 to 15 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Partial or total Exclusion Criteria:

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

Trial design

70 participants in 2 patient groups

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

Description:

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

Treatment:

Other: 3 tesla magnetic resonance imaging findings; coronary artery status

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

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

Description:

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

Treatment:

Other: 3 tesla magnetic resonance imaging findings; coronary artery status

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