COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00112424
Recruitment Status : Completed
First Posted : June 3, 2005
Last Update Posted : January 31, 2008
Information provided by:
Boston Children's Hospital

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.

Condition or disease Intervention/treatment Phase
Congenital Heart Defects Procedure: Diagnostic cardiac MRI Procedure: Cardiac catheterization Not Applicable

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).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Clinical Trial of Cardiac Magnetic Resonance Imaging in Routine Evaluation Prior to Superior Cavo-Pulmonary Anastomosis
Study Start Date : January 2004
Actual Primary Completion Date : June 2006
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

Intervention Details:
  • Procedure: Diagnostic cardiac MRI
    Routine cardiac MRI done under general anesthesia as pre-operative evaluation.
    Other Name: Cardiac Magnetic Resonance
  • Procedure: Cardiac catheterization
    Routine cardiac catheterization prior to Glenn operation.
    Other Name: Cardiac cath.

Primary Outcome Measures :
  1. Toxicity profile for each group [ Time Frame: 3 Months Post-Glenn operation ]

Secondary Outcome Measures :
  1. Operative and post-operative outcomes [ Time Frame: 30 days post-operation ]
  2. Missed diagnoses [ Time Frame: 3 months post-Glenn operation ]
  3. Cost [ Time Frame: Pre-operative evaluation ]
  4. Clinical Definition of successful Glenn operation [ Time Frame: 3 months post-operatively ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   6 Weeks to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Single ventricle heart disease patients presenting for Glenn operation

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00112424

Layout table for location information
United States, Massachusetts
Childrens Hospital, Boston
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Boston Children's Hospital
Layout table for investigator information
Principal Investigator: David W. Brown, MD Childrens Hospital Boston
Layout table for additonal information
Responsible Party: David W. Brown, MD. Principal Investigator, Childrens Hospital Boston Identifier: NCT00112424    
Other Study ID Numbers: CH 02-12-155
First Posted: June 3, 2005    Key Record Dates
Last Update Posted: January 31, 2008
Last Verified: January 2008
Keywords provided by Boston Children's Hospital:
Superior cavo-pulmonary anastomosis
Glenn operation
Congenital heart defects
Cardiac magnetic resonance imaging
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities