Trial of Cardiac Magnetic Resonance Imaging (MRI) Versus Cardiac Catheterization Prior to Glenn Operation

Clinical Trial of Cardiac Magnetic Resonance Imaging in Routine Evaluation Prior to Superior Cavo-Pulmonary Anastomosis

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.

Study Overview

• Status: Completed
• Conditions: Congenital Heart Defects
• Intervention / Treatment: Procedure: Diagnostic cardiac MRI; Procedure: Cardiac catheterization

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).

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Childrens Hospital, Boston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Single ventricle heart disease patients presenting for Glenn operation

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Toxicity profile for each group	3 Months Post-Glenn operation

Secondary Outcome Measures

Outcome Measure	Time Frame
Operative and post-operative outcomes	30 days post-operation
Missed diagnoses	3 months post-Glenn operation
Cost	Pre-operative evaluation
Clinical Definition of successful Glenn operation	3 months post-operatively

Collaborators and Investigators

• Sponsor: Boston Children's Hospital
• Investigators: Principal Investigator: David W. Brown, MD, Childrens Hospital Boston

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2004
• Primary Completion (Actual): June 1, 2006
• Study Completion (Actual): January 1, 2008

Study Registration Dates

• First Submitted: June 2, 2005
• First Submitted That Met QC Criteria: June 2, 2005
• First Posted (Estimate): June 3, 2005

Study Record Updates

• Last Update Posted (Estimate): January 31, 2008
• Last Update Submitted That Met QC Criteria: January 29, 2008
• Last Verified: January 1, 2008

More Information

Terms related to this study

• Keywords: Congenital heart defects; Cardiac magnetic resonance imaging; Glenn operation; Superior cavo-pulmonary anastomosis
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Defects, Congenital
• Other Study ID Numbers: CH 02-12-155