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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.
 
ClinicalTrials.gov Identifier: NCT00112424
Recruitment Status : Completed
First Posted : June 3, 2005
Last Update Posted : January 31, 2008
Sponsor:
Information provided by:
Boston Children's Hospital

Tracking Information
First Submitted Date  ICMJE June 2, 2005
First Posted Date  ICMJE June 3, 2005
Last Update Posted Date January 31, 2008
Study Start Date  ICMJE January 2004
Actual Primary Completion Date June 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 29, 2008)
Toxicity profile for each group [ Time Frame: 3 Months Post-Glenn operation ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
Toxicity profile for each group
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 29, 2008)
  • Operative and post-operative outcomes [ Time Frame: 30 days post-operation ]
  • Missed diagnoses [ Time Frame: 3 months post-Glenn operation ]
  • Cost [ Time Frame: Pre-operative evaluation ]
  • Clinical Definition of successful Glenn operation [ Time Frame: 3 months post-operatively ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
  • Achievement of clinical definition of good clinical outcome
  • Operative and post-operative outcomes
  • Missed diagnoses
  • Cost
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial of Cardiac Magnetic Resonance Imaging (MRI) Versus Cardiac Catheterization Prior to Glenn Operation
Official Title  ICMJE Clinical Trial of Cardiac Magnetic Resonance Imaging in Routine Evaluation Prior to Superior Cavo-Pulmonary Anastomosis
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Congenital Heart Defects
Intervention  ICMJE
  • 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.
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 23, 2005)
80
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2008
Actual Primary Completion Date June 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Single ventricle heart disease patients presenting for Glenn operation

Exclusion Criteria:

  • Aortic arch obstruction
  • Pulmonary vein stenoses
  • Severe ventricular dysfunction
  • Pulmonary hypertension
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Weeks to 5 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00112424
Other Study ID Numbers  ICMJE CH 02-12-155
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party David W. Brown, MD. Principal Investigator, Childrens Hospital Boston
Study Sponsor  ICMJE Boston Children's Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David W. Brown, MD Childrens Hospital Boston
PRS Account Boston Children's Hospital
Verification Date January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP