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

Study Overview
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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).

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

Conditions
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Transposition of Great Vessels, Surgery

Intervention / Treatment
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* Other: 3 tesla magnetic resonance imaging findings; coronary artery status
* Other: 3 tesla magnetic resonance imaging findings; ventricular function and morphology


Participation Criteria
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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 Partial or total Exclusion Criteria: Heart arrhythmias Known allergic reaction to gadolinium based contrast media Reduced renal function (below 60 ml/min/1,73m2)

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Switch trap-door re-implantation of the coronaries<br>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 status<br> <br> Other: 3 tesla magnetic resonance imaging findings; ventricular function and morphology<br> <br> |
| Switch non-trap-door re-implantation of the coronaries<br>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 status<br> <br> Other: 3 tesla magnetic resonance imaging findings; ventricular function and morphology<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Child, adolescent, Coronary artery disease, Magnetic resonance imaging