Transposition of Great VesselsNCT01916499
MRI Study After Arterial Switch Operation in Patients With Transposition of the Great Arteries
An observational study of Transposition of Great Vessels and Surgery, run by Oslo University Hospital at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 10 to 15 years
- Conditions the study is for
- Transposition of Great Vessels, Surgery
- What is being tested?
- 3 tesla magnetic resonance imaging findings; coronary artery status and 3 tesla magnetic resonance imaging findings; ventricular function and morphology
- How many people
- 70 participants
- Where
- 1 siteNorway
- Study dates
- May 2012to Jan 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 15 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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).
- Conditions
- Transposition of Great Vessels, Surgery
- Being tested
- 3 tesla magnetic resonance imaging findings; coronary artery status, 3 tesla magnetic resonance imaging findings; ventricular function and morphology
- Keywords
- Child, adolescent, Coronary artery disease, Magnetic resonance imaging
- Medical subject headings
- Transposition of Great Vessels, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3 tesla magnetic resonance imaging findings; coronary artery statusOther
3 tesla magnetic resonance imaging findings; ventricular function and morphologyOther
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: 3 tesla magnetic resonance imaging findings; coronary artery status; Other: 3 tesla magnetic resonance imaging findings; ventricular function and morphology |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 10-15 years after surgery
Secondary outcomes (2)
Comparison of image quality of direct visualization of the coronary arteries with and without contrast enhanced techniques.
Measured: 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.
Measured: 10-15 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2013 (estimated)
- Study startMay 2012
- Primary completionApr 2015
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transposition of Great VesselsStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kathrine Rydén Suther, Oslo University Hospital
- Investigators
- Charlotte De Lange, MD PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01916499
- Sponsor's protocol ID
- 2011/1422
- Status last verified
- May 2017
- First submitted
- 2 Aug 2013
- Last updated
- 25 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI Study After Arterial Switch Operation in Patients With Transposition of the Great Arteries
- ClinicalTrials.gov ID
- NCT01916499
- Acronym / sponsor ID
- 2011/1422
- Conditions
- Transposition of Great Vessels, Surgery
- Keywords
- Child, adolescent, Coronary artery disease, Magnetic resonance imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- May 2012 (actual)
- Primary completion
- Apr 2015 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 5 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Switch "trap-door" re-implantation of the coronaries | – | Other: 3 tesla magnetic resonance imaging findings; coronary artery status, Other: 3 tesla magnetic resonance imaging findings; ventricular function and morphologyRe-implantation of the coronary arteries into the neo-aortic sinuses through a "trap-door" as far distally as possible on the neo-aorta |
| Switch non-"trap-door" re-implantation of the coronaries | – | Other: 3 tesla magnetic resonance imaging findings; coronary artery status, Other: 3 tesla magnetic resonance imaging findings; ventricular function and morphologyRe-implantation of the coronary arteries into the neo-aortic sinuses through small incisions or excision in the sinuses |
Who may qualify
- Ages
- 10 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (6 listed)
- Clinical diagnosis of transposition of the great arteries with or without ventricular septum defect
- Surgically corrected during neonatal period with arterial switch procedure
- Heart arrhythmias
- Known allergic reaction to gadolinium based contrast media
- Reduced renal function (below 60 ml/min/1,73m2)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3 tesla magnetic resonance imaging findings; coronary artery status | Other | Switch "trap-door" re-implantation of the coronaries, Switch non-"trap-door" re-implantation of the coronaries |
| 3 tesla magnetic resonance imaging findings; ventricular function and morphology | Other | Switch "trap-door" re-implantation of the coronaries, Switch non-"trap-door" re-implantation of the coronaries |
Primary outcome
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
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charlotte De Lange, MD PhD principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transposition of Great Vessels and Surgery, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2017.