Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00112424
Status:
COMPLETED
Last Update Posted:
2008-01-31
First Post:
2005-06-02
Brief Title:
Trial of Cardiac Magnetic Resonance Imaging MRI Versus Cardiac Catheterization Prior to Glenn Operation
Sponsor:
Boston Childrens Hospital
Organization:
Boston Childrens Hospital
Study Overview
Official Title:
Clinical Trial of Cardiac Magnetic Resonance Imaging in Routine Evaluation Prior to Superior Cavo-Pulmonary Anastomosis
Status:
COMPLETED
Status Verified Date:
2008-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a prospective randomized study of patients with single ventricle heart disease who are to undergo superior cavo-pulmonary anastomosis or Glenn operation Such patients have historically undergone cardiac catheterization to ensure suitability for the procedure Cardiac magnetic resonance imaging cardiac MRI is a newer technology that provides excellent anatomic and functional imaging of the heart This study is designed to demonstrate our hypothesis that cardiac magnetic resonance imaging will provide comparable information to catheterization with less side effects
Detailed Description:
This is a prospective randomized study of patients with single ventricle congenital heart disease presenting for superior cavo-pulmonary anastomosis or Glenn operation Such patients in the past have routinely undergone pre-operative invasive cardiac catheterization to assess anatomic and hemodynamic suitability for this procedure Recent retrospective reviews including our own J Thorac Cardiovasc Surg 2003 July1261272-81 have suggested that such catheterization may not benefit many patients and that non-invasive assessment may allow adequate evaluation while avoiding many typically minor complications seen with cardiac catheterization in this high risk group of infants Cardiac MRI is a non-invasive imaging modality that can deliver superior anatomic information such as vascular and intracardiac anatomy as well as functional data ventricular volumes and ejection fraction and may be a safe alternative to catheterization in such patients In this study patients undergo screening echocardiogram prior to enrollment in the study to assess degree of risk for the operation such as pulmonary vein obstruction a clear risk factor for poor outcome or for demonstrated need for catheterization intervention such as aortic arch obstruction requiring balloon dilation patients with low risk echocardiograms whose parents grant informed consent for the study are then randomized in a prospective fashion to cardiac MRI or cardiac catheterization The findings of each study are then reviewed by the subjects cardiologist and cardiac surgeon patients in whom further pre-operative information may cross over to another study if deemed necessary such as catheterization in patients in whom an unsuspected finding is noted or cardiac MRI in patients in whom further functional data may be desired Patients are followed for details of the hospital stay including hospital length of stay complications hospital charges for the pre-operative testing as well as operative and post-operative outcomes newmissed diagnoses hospital stay operative and post-operative complications achievement of a clinical definition of a good outcome from the Glenn operation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None