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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01916499
First Posted: August 5, 2013
Last Update Posted: May 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Kathrine Rydén Suther, Oslo University Hospital
  Purpose
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.

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

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: MRI Study After Arterial Switch Operation in Patients With Transposition of the Great Arteries

Resource links provided by NLM:


Further study details as provided by Kathrine Rydén Suther, Oslo University Hospital:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Comparison of image quality of direct visualization of the coronary arteries with and without contrast enhanced techniques. [ Time Frame: 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. [ Time Frame: 10-15 years after surgery ]

Enrollment: 70
Actual Study Start Date: May 2012
Study Completion Date: January 2017
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Switch "trap-door" re-implantation of the coronaries
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 Other: 3 tesla magnetic resonance imaging findings; ventricular function and morphology
Switch non-"trap-door" re-implantation of the coronaries
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 Other: 3 tesla magnetic resonance imaging findings; ventricular function and morphology

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).
  Eligibility

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Ages Eligible for Study:   10 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients 10-15 years old surgically corrected in the neonatal period with arterial switch procedure for transposition of the great arteries at Rikshospitalet, OUS, Norway.
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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01916499


Locations
Norway
Oslo University Hospital, Rikshospitalet
Oslo, Norway, 0424
Sponsors and Collaborators
Oslo University Hospital
Investigators
Principal Investigator: Charlotte De Lange, MD PhD Oslo University Hospital
  More Information

Responsible Party: Kathrine Rydén Suther, MD, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01916499     History of Changes
Other Study ID Numbers: 2011/1422
First Submitted: August 2, 2013
First Posted: August 5, 2013
Last Update Posted: May 25, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Kathrine Rydén Suther, Oslo University Hospital:
Child, adolescent
Coronary artery disease
Magnetic resonance imaging

Additional relevant MeSH terms:
Situs Inversus
Transposition of Great Vessels
Congenital Abnormalities
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases