Trial record 1 of 20 for:    "Transposition of the great arteries"
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MRI Study After Arterial Switch Operation in Patients With Transposition of the Great Arteries

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Kathrine Rydén Suther, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01916499
First received: August 2, 2013
Last updated: NA
Last verified: August 2013
History: No changes posted
  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 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: May 2012
Estimated Primary Completion Date: September 2014 (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

Ages Eligible for Study:   10 Years to 15 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Kathrine Rydén Suther, MD, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01916499     History of Changes
Other Study ID Numbers: 2011/1422
Study First Received: August 2, 2013
Last Updated: August 2, 2013
Health Authority: Norway: Ministry of Health and Care Services

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

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

ClinicalTrials.gov processed this record on October 30, 2014