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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01916499
• Other study ID #: 2011/1422
• Status: Completed
• Phase: N/A
• First received: August 2, 2013
• Last updated: May 23, 2017
• Start date: May 2012
• Est. completion date: January 2017

Study information

• Verified date: May 2017
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: January 2017
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 15 Years

Eligibility

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)

Related Conditions & MeSH terms

• Situs Inversus
• Surgery
• Transposition of Great Vessels

Intervention

Other:
• 3 tesla magnetic resonance imaging findings; coronary artery status

• 3 tesla magnetic resonance imaging findings; ventricular function and morphology

Locations

Country	Name	City	State
Norway	Oslo University Hospital, Rikshospitalet	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Comparison of image quality of direct visualization of the coronary arteries with and without contrast enhanced techniques.		10-15 years after surgery
Secondary	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