Myocardial IschemiaIRCADONCT02542345
Comparative Assessment of Coronary MR Angiography Vs Coronary Multislice CT After Coronary Artery Reimplantation in Children and Young Adults.
A study testing magnetic resonance imaging in people with Myocardial Ischemia, run by Centre Chirurgical Marie Lannelongue at 1 site in France.
Trial summary
This is a prospective, multicentric study conducted in order to evaluate if MRI coronarography is as powerful as Cardiac Multislice CT in detection of coronary abnormalities after coronary reimpantation in children over 5 yo, teenagers and young adults who underwent coronary reimplantation in childhood. Read more about this study
- Who is it for?
- Ages 5 to 30 years
- Conditions the study is for
- Myocardial Ischemia
- What is being tested?
- magnetic resonance imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteFrance
- Study dates
- May 2011to Jun 2018
- Phase
- Interventional
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 5 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Non randomized patients requiring coronary imaging with cardiac CT
- for prior coronary reimplantation (arterial Switch, Ross procedure, ACAPA)
- aged of 5 years old or more,
- cooperating, requiring no sedation for MR examination
- Without contra indication to MR examination
Who cannot join
- Less than 5 years old
- Presenting a contra indication to MR examination
- Non cooperant
- Claustrophobic
- No informed consent
- For teenage girl, no pregnant test available
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Chirurgical Marie Lannelongue
Le Plessis-Robinson, 92350
Anne Sigal, MD, +33140942517
About this study
This is a prospective, multicentric study conducted in order to evaluate if MRI coronarography is as powerful as Cardiac Multislice CT in detection of coronary abnormalities after coronary reimpantation in children over 5 yo, teenagers and young adults who underwent coronary reimplantation in childhood.
Newborns suffering from transposition of the great vessels who underwent at neonatal age an arterial switch operation (ASO) with coronary reimplantation, may develop in time with growth, stenosis, twist or elongation of the reimplanted coronary artery, which may cause myocardial ischemia. As well, aortic root surgery such as the Ross procedure and abnomalous coronary artery from pulmonary artery (ACAPA) reimplantation may lead to the same complications. Functional ischemic tests in a combination of three minimum are positive in only 75% of the cases . Silent ischemia due to coronary abnormality is to be detected in those patients.
Read more
In those patients, coronarography was recommended to be performed at least at 7 and 15 yo, without any clinical symptoms . It has also been recommended to examine those patients at 5, 10 and 15 yo as growth is the main cause for coronary abnormality development. Cardiac CT has been proven to be as efficient as coronarography to depict coronary reimplantation abnormalities .
Due to the invasiveness of angiography and to the development of cardiac CT, in our institution, the attitude is to performed cardiac CT instead of angiography with the same frequency in our patients.
Coronaro MRI has been established as a valid technique for evaluation of coronary arteries in patients after ASO .
The aim of this study is to evaluate if non contrast 3D MR coronarography is as powerful as Cardiac Multislice CT for the depiction of coronary anomalies.
All patients, with prior ASO, Ross or ACAPA reimplantation, refereed for cardiac CT and eligible for MRI, over 5yo are included in this prospective multi centric study.
Both examinations are performed on the same day after informed consent, from the patient or from both parents if minor.
Cardiac CT is performed according to the usual protocol in our institution, and MR coronaro angiography is performed as follow: excluding any contra indication to MR, the study requires one or two maximum 3D true FISP sequence without IV contrast injection, with cardiac gating, and free breathing.
3D images are evaluated blinded to the results of cardiac CT by two senior radiologists, with at least 5 years of experience in MR and CT cardiac imaging.
Comparison of the results is consolidated afterwards. Other elements evaluated are tolerance and feasibility of the examination.
The study is designed for four years and benefits from a grant from the Assistance Publique-Hopitaux de Paris.
- Conditions
- Myocardial Ischemia
- Being tested
- magnetic resonance imaging
- Keywords
- Cardiac Multislice CT, MRI coronarography
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
magnetic resonance imagingProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| magnetic resonance imaging | Experimental | Not described Receives: Procedure: magnetic resonance imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of stenosis, performed on 3D workstations, reported in percentage (<50%, 50-70%, 70%) relative to the diameter of the normal vessel immediately below the stenosis.
Measured: The CT and MR examination are done the same day. There is no fixed time frame between the examinations and the measurements as the analysis is performed with a pooling of 30 patients at the same time. The time frame is variable, it ranges from 1 week to
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2015 (estimated)
- Study startMay 2011
- Primary completionDec 2017 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial IschemiaStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Chirurgical Marie Lannelongue
- Sponsor type
- University, hospital or other
- Collaborators
- Hopital Universitaire Robert-Debre, Amiens University Hospital, University Hospital, Caen, University Hospital, Rouen, University Hospital, Tours
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02542345
- Sponsor's protocol ID
- 2011-A00372-39
- Acronym
- IRCADO
- Status last verified
- Mar 2016
- First submitted
- 1 Sep 2015
- Last updated
- 2 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes