Trial of Cardiac Magnetic Resonance Imaging (MRI) Versus Cardiac Catheterization Prior to Glenn Operation
Condition: Congenital Heart Defects
MeSH terms: Heart Defects, Congenital
Study type: Interventional

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: July;126(1):272-81) 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 subject's
      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 (new/missed diagnoses, hospital stay, operative and
      post-operative complications, achievement of a clinical definition of a "good" outcome from
      the Glenn operation).
    

Intervention name(s): Diagnostic cardiac MRI; Cardiac catheterization
Intervention type(s): Procedure; Procedure
Intervention description(s): Routine cardiac MRI done under general anesthesia as pre-operative evaluation.; Routine cardiac catheterization prior to Glenn operation.
Other intervention name(s): Cardiac Magnetic Resonance; Cardiac cath.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Superior cavo-pulmonary anastomosis; Glenn operation; Congenital heart defects; Cardiac magnetic resonance imaging