NCT00112424

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

June 2, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 3, 2005

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

January 31, 2008

Status Verified

January 1, 2008

Enrollment Period

2.4 years

First QC Date

June 2, 2005

Last Update Submit

January 29, 2008

Conditions

Congenital Heart Defects

Keywords

Superior cavo-pulmonary anastomosisGlenn operationCongenital heart defectsCardiac magnetic resonance imaging

Outcome Measures

Primary Outcomes (1)

  • Toxicity profile for each group

    3 Months Post-Glenn operation

Secondary Outcomes (4)

  • 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

Interventions

Diagnostic cardiac MRIPROCEDURE

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

Also known as: Cardiac Magnetic Resonance
Cardiac catheterizationPROCEDURE

Routine cardiac catheterization prior to Glenn operation.

Also known as: Cardiac cath.

Eligibility Criteria

Age6 Weeks - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Single ventricle heart disease patients presenting for Glenn operation

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Childrens Hospital, Boston

Boston, Massachusetts, 02115, United States

Location

Related Publications (2)

  • 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.

    PMID: 12878965BACKGROUND

  • 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.

    PMID: 15234431BACKGROUND

MeSH Terms

Conditions

Heart Defects, Congenital

Interventions

Cardiac Catheterization

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisCatheterizationTherapeuticsInvestigative Techniques

Study Officials

  • David W. Brown, MD

    Childrens Hospital Boston

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 2, 2005

First Posted

June 3, 2005

Study Start

January 1, 2004

Primary Completion

June 1, 2006

Study Completion

January 1, 2008

Last Updated

January 31, 2008

Record last verified: 2008-01

Locations

US(1)