Comparative Assessment of Coronary MR Angiography Vs Coronary Multislice CT After Coronary Artery Reimplantation in Children and Young Adults. (IRCADO)
Primary Purpose
Myocardial Ischemia
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
magnetic resonance imaging
Sponsored by
About this trial
This is an interventional diagnostic trial for Myocardial Ischemia focused on measuring Cardiac Multislice CT, MRI coronarography
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Centre Chirurgical Marie LannelongueRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
magnetic resonance imaging
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02542345
First Posted
September 1, 2015
Last Updated
June 29, 2017
Sponsor
Centre Chirurgical Marie Lannelongue
Collaborators
Hopital Universitaire Robert-Debre, Amiens University Hospital, University Hospital, Caen, University Hospital, Rouen, University Hospital, Tours
1. Study Identification
Unique Protocol Identification Number
NCT02542345
Brief Title
Comparative Assessment of Coronary MR Angiography Vs Coronary Multislice CT After Coronary Artery Reimplantation in Children and Young Adults.
Acronym
IRCADO
Official Title
Comparative Assessment of Coronary MR Angiography Vs Coronary Multislice CT After Coronary Artery Reimplantation in Children and Young Adults.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 2011 (Actual)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
June 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Chirurgical Marie Lannelongue
Collaborators
Hopital Universitaire Robert-Debre, Amiens University Hospital, University Hospital, Caen, University Hospital, Rouen, University Hospital, Tours
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Ischemia
Keywords
Cardiac Multislice CT, MRI coronarography
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
magnetic resonance imaging
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
magnetic resonance imaging
Primary Outcome Measure Information:
Title
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.
Time Frame
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Facility Information:
Facility Name
Centre Chirurgical Marie Lannelongue
City
Le Plessis Robinson
ZIP/Postal Code
92350
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Sigal, MD
Phone
+33140942517
12. IPD Sharing Statement
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Comparative Assessment of Coronary MR Angiography Vs Coronary Multislice CT After Coronary Artery Reimplantation in Children and Young Adults.
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