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

Related Clinical Trial
Clinical Impact of Rapid Prototyping 3D Models for Surgical Management A Retrospective Comparison of the Efficacy and Safety of Celsior® in Pediatric Cardiac Surgery for Transposition of the Great Vessels Comprehensive Long-term Follow up of Adults With Arterial Switch Operation Erythropoetin Neuroprotection for Neonatal Cardiac Surgery Initiation of Resuscitation While Attached to the Cord With Congenital Heart Disease Canadian Adult Congenital Heart Disease Intervention Registry Physical Training in Transposition of the Great Arteries Eplerenone in Systemic Right Ventricle N-Acetylcysteine in Neonatal Congenital Heart Surgery (INACT Study) Genetic Determinants of Congenital Heart Disease Outcomes Myocardial Contrast Echocardiography in Congenital Heart Disease Sudden Cardiac Death in Systemic Right Ventricle Haemodynamics and Function of the Atria in Congenital Heart Disease by Cardiovascular Magnetic Resonance The Boston Circulatory Arrest Study: Antecedents and Correlates of Well-Being in Adults With Congenital Heart Disease Comparison of Hematocrit Levels in Infant Heart Surgery Late Function After Surgery for Transposition of the Great Arteries Acute Maternal Hyperoxygenation for Fetal Transposition of the Great Arteries (TGA) MRI Study After Arterial Switch Operation in Patients With Transposition of the Great Arteries Fibrosis, Valvular and Ventricular Function in Patients With TGA Characterization of the Cardiac Reinnervation of Patients With Transposition of the Great Arteries Long After Repair With the Arterial Switch Operation. Correlation With Electrocardiographic and Exercise Test Parameters Cardiovascular MRI and Cardiopulmonary Exercise Capacity After Neonatal ASO) in Young Adults Nitric Oxide During Bypass for Arterial Switch Operation

Brief Title

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

Official Title

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

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 Type

Observational


Primary Outcome

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).

Secondary Outcome

 Comparison of image quality of direct visualization of the coronary arteries with and without contrast enhanced techniques.

Condition

Transposition of Great Vessels

Intervention

3 tesla magnetic resonance imaging findings; coronary artery status

Study Arms / Comparison 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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

70

Start Date

May 2012

Completion Date

January 2017

Primary Completion Date

April 2015

Eligibility 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)
      

Gender

All

Ages

10 Years - 15 Years

Accepts Healthy Volunteers

No

Contacts

Charlotte De Lange, MD PhD, , 

Location Countries

Norway

Location Countries

Norway

Administrative Informations


NCT ID

NCT01916499

Organization ID

2011/1422


Responsible Party

Principal Investigator

Study Sponsor

Oslo University Hospital


Study Sponsor

Charlotte De Lange, MD PhD, Principal Investigator, Oslo University Hospital


Verification Date

May 2017