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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2008-01-31

Brief Summary

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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

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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).

Conditions

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Congenital Heart Defects

Keywords

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Superior cavo-pulmonary anastomosis Glenn operation Congenital heart defects Cardiac magnetic resonance imaging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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Diagnostic cardiac MRI

Routine cardiac MRI done under general anesthesia as pre-operative evaluation.

Intervention Type PROCEDURE

Cardiac catheterization

Routine cardiac catheterization prior to Glenn operation.

Intervention Type PROCEDURE

Other Intervention Names

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Cardiac Magnetic Resonance Cardiac cath.

Eligibility Criteria

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Inclusion Criteria

* Single ventricle heart disease patients presenting for Glenn operation

Exclusion Criteria

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

Minimum Eligible Age

6 Weeks

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Childrens Hospital Boston

Principal Investigators

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David W. Brown, MD

Role: PRINCIPAL_INVESTIGATOR

Childrens Hospital Boston

Locations

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Childrens Hospital, Boston

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND

PMID: 12878965 (View on PubMed)

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.