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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01916499

Enrollment

Registered

2013-08-05

Start date

2012-05-31

Completion date

2017-01-31

Last updated

2017-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgery, Transposition of Great Vessels

Keywords

Child, adolescent, Coronary artery disease, Magnetic resonance imaging

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).

Interventions

OTHER3 tesla magnetic resonance imaging findings; coronary artery status

OTHER3 tesla magnetic resonance imaging findings; ventricular function and morphology

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

10 Years to 15 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	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

Measure	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

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026