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

Completed

• Conditions: Surgery; Transposition of Great Vessels
• Interventions: Other: 3 tesla magnetic resonance imaging findings; coronary artery status; Other: 3 tesla magnetic resonance imaging findings; ventricular function and morphology

• Registration Number: NCT01916499
• Lead Sponsor: Oslo University Hospital

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.

Detailed 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).

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2013-08-02
• Study First Submitted QC: 2013-08-02
• Study First Posted: 2013-08-05
• Primary Completion: 2015-04
• Study Completion: 2017-01
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-23
• Last Update Posted: 2017-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Switch non-"trap-door" re-implantation of the coronaries	3 tesla magnetic resonance imaging findings; ventricular function and morphology	Re-implantation of the coronary arteries into the neo-aortic sinuses through small incisions or excision in the sinuses
Switch "trap-door" re-implantation of the coronaries	3 tesla magnetic resonance imaging findings; coronary artery status	Re-implantation of the coronary arteries into the neo-aortic sinuses through a "trap-door" as far distally as possible on the neo-aorta
Switch non-"trap-door" re-implantation of the coronaries	3 tesla magnetic resonance imaging findings; coronary artery status	Re-implantation of the coronary arteries into the neo-aortic sinuses through small incisions or excision in the sinuses
Switch "trap-door" re-implantation of the coronaries	3 tesla magnetic resonance imaging findings; ventricular function and morphology	Re-implantation of the coronary arteries into the neo-aortic sinuses through a "trap-door" as far distally as possible on the neo-aorta

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Oslo University Hospital, Rikshospitalet; 🇳🇴 Oslo, Norway