Congenital Heart DefectsNCT00112424
Trial of Cardiac Magnetic Resonance Imaging (MRI) Versus Cardiac Catheterization Prior to Glenn Operation
A study testing Diagnostic cardiac MRI and Cardiac catheterization in people with Congenital Heart Defects, run by Boston Children's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 weeks to 5 years
- Conditions the study is for
- Congenital Heart Defects
- What is being tested?
- Diagnostic cardiac MRI and Cardiac catheterization
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2004to Jan 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 weeks to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Single ventricle heart disease patients presenting for Glenn operation
Who cannot join
- Aortic arch obstruction
- Pulmonary vein stenoses
- Severe ventricular dysfunction
- Pulmonary hypertension
Trial locations and contacts
1 site in 1 country.
United States1 site
Childrens Hospital, Boston
Boston, Massachusetts, 02115
About this study
Official title: 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.
Read the 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).
- Conditions
- Congenital Heart Defects
- Being tested
- Diagnostic cardiac MRI, Cardiac catheterization
- Keywords
- Superior cavo-pulmonary anastomosis, Glenn operation, Congenital heart defects, Cardiac magnetic resonance imaging
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic cardiac MRIProcedure or surgery
Also called Cardiac Magnetic Resonance
Routine cardiac MRI done under general anesthesia as pre-operative evaluation.
Cardiac catheterizationProcedure or surgery
Also called Cardiac cath.
Routine cardiac catheterization prior to Glenn operation.
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicity profile for each group
Measured: 3 Months Post-Glenn operation
Secondary outcomes (4)
Operative and post-operative outcomes
Measured: 30 days post-operation
Missed diagnoses
Measured: 3 months post-Glenn operation
Cost
Measured: Pre-operative evaluation
Clinical Definition of successful Glenn operation
Measured: 3 months post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2005 (estimated)
- Study startJan 2004
- Primary completionJun 2006
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart DefectsStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Investigators
- David W. Brown, MD, Principal investigator, Childrens Hospital Boston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00112424
- Sponsor's protocol ID
- CH 02-12-155
- Status last verified
- Jan 2008
- First submitted
- 2 Jun 2005
- Last updated
- 31 Jan 2008
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 12878965Ro 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.
PubMed 15234431
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of Cardiac Magnetic Resonance Imaging in Routine Evaluation Prior to Superior Cavo-Pulmonary Anastomosis
- ClinicalTrials.gov ID
- NCT00112424
- Acronym / sponsor ID
- CH 02-12-155
- Conditions
- Congenital Heart Defects
- Keywords
- Superior cavo-pulmonary anastomosis, Glenn operation, Congenital heart defects, Cardiac magnetic resonance imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- Jan 2004
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 3 Jun 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 6 weeks to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Single ventricle heart disease patients presenting for Glenn operation
Key exclusion criteria (4 listed)
- Aortic arch obstruction
- Pulmonary vein stenoses
- Severe ventricular dysfunction
- Pulmonary hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic cardiac MRIAlso: Cardiac Magnetic ResonanceRoutine cardiac MRI done under general anesthesia as pre-operative evaluation. | Procedure or surgery | – |
| Cardiac catheterizationAlso: Cardiac cath.Routine cardiac catheterization prior to Glenn operation. | Procedure or surgery | – |
Primary outcome
Toxicity profile for each group
Time frame: 3 Months Post-Glenn operation
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2008.
- Background: PubMed 12878965Brown 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.
- Background: PubMed 15234431Ro 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.
Related trials for Congenital Heart Defects
Not yet recruiting
Autologous Thymus Transplant in Children With Congenital Heart Disease: A Pilot Study
Congenital Heart Disease (CHD)
RecruitingPhase 3
Trial Investigating the Efficacy and Safety of Weekly Lonapegsomatropin Compared to Daily Somatropin in Children and Adolescents With Short Stature or Growth Failure Due to Growth Hormone Sufficient Disorders
Turner Syndrome, Short Stature Homeobox Gene Mutation
Not yet recruitingObservational study
Hummingbird ICE Study
ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION, Atrial Fibrillation (AF)
Active, not recruiting
Learning by Heart: The Effectiveness of an EF Training Program for Pre-schoolers With Critical CHD
Congenital Heart Disease, Executive Dysfunction
Recruiting
Discontinuation of Antithrombotic Treatment Following Patent Foramen Ovale Closure in Young Patients With Cryptogenic Stroke
Patent Foramen Ovale, Ischemic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David W. Brown, MD principal investigator
Childrens Hospital Boston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diagnostic cardiac MRI and Cardiac catheterization in people with Congenital Heart Defects, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Toxicity profile for each group (time frame: 3 Months Post-Glenn operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00112424, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2008.