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Completed

NCT Number: NCT01916499

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

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.

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Key information

Conditions

Transposition of Great Vessels Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Coronary Artery Disease Coronary Disease Heart Defects, Congenital Heart Diseases Myocardial Ischemia Surgery Vascular Diseases

Age range

10 year–15 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Oslo University Hospital, Rikshospitalet

Oslo, 0424, Norway

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

3 tesla magnetic resonance imaging findings; coronary artery status

Other

3 tesla magnetic resonance imaging findings; ventricular function and morphology

Other

Primary outcomes

  1. 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).

    Time frame: 10-15 years after surgery

Secondary outcomes

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

    Time frame: 10-15 years after surgery

  2. Comparison of coronary artery findings corresponding to indirect functional and morphological findings in MRI and echocardiography in the left and right ventricle.

    Time frame: 10-15 years after surgery

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2017
First posted
Aug 5, 2013
Registry last updated
May 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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