Clinical trial NCT00112424: Trial of Cardiac Magnetic Resonance Imaging (MRI) Versus Cardiac Catheterization Prior to Glenn Operation
Official title: Clinical Trial of Cardiac Magnetic Resonance Imaging in Routine Evaluation Prior to Superior Cavo-Pulmonary Anastomosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congenital Heart Defects
Keywords: Superior cavo-pulmonary anastomosis
Glenn operation
Congenital heart defects
Cardiac magnetic resonance imaging
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2005-06-03
Enrollment: 80
Sex: ALL
Minimum age (years): 6
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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: 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).

Eligibility criteria: Inclusion Criteria:

* Single ventricle heart disease patients presenting for Glenn operation

Exclusion Criteria:

* Aortic arch obstruction
* Pulmonary vein stenoses
* Severe ventricular dysfunction
* Pulmonary hypertension

Primary outcomes:
measure: Toxicity profile for each group
timeFrame: 3 Months Post-Glenn operation
Secondary outcomes:
measure: Operative and post-operative outcomes
timeFrame: 30 days post-operation
measure: Missed diagnoses
timeFrame: 3 months post-Glenn operation
measure: Cost
timeFrame: Pre-operative evaluation
measure: Clinical Definition of successful Glenn operation
timeFrame: 3 months post-operatively
Other outcomes:
Locations:
city: Boston
country: United States
facility: Childrens Hospital, Boston
state: Massachusetts
Study officials:
affiliation: Childrens Hospital Boston
name: David W. Brown, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brown DW, Gauvreau K, Moran AM, Jenkins KJ, Perry SB, del Nido PJ, Colan SD. Clinical outcomes and utility of cardiac catheterization prior to superior cavopulmonary anastomosis. J Thorac Cardiovasc Surg. 2003 Jul;126(1):272-81. doi: 10.1016/s0022-5223(03)00054-0.
citation: Ro PS, Rychik J, Cohen MS, Mahle WT, Rome JJ. Diagnostic assessment before Fontan operation in patients with bidirectional cavopulmonary anastomosis: are noninvasive methods sufficient? J Am Coll Cardiol. 2004 Jul 7;44(1):184-7. doi: 10.1016/j.jacc.2004.02.058.