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

May 23, 2017 updated by: Kathrine Rydén Suther, Oslo University Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 0424
        • Oslo University Hospital, Rikshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome 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).
Time Frame: 10-15 years after surgery
10-15 years after surgery

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2012

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

August 2, 2013

First Submitted That Met QC Criteria

August 2, 2013

First Posted (Estimate)

August 5, 2013

Study Record Updates

Last Update Posted (Actual)

May 25, 2017

Last Update Submitted That Met QC Criteria

May 23, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011/1422

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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