Respiratory Motion Analysis in Children With MRI
Recruitment status was Recruiting
|First Received Date ICMJE||August 18, 2006|
|Last Updated Date||September 10, 2008|
|Start Date ICMJE||August 2006|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||cardiac motion reduction in cardiac MRI images [ Time Frame: throughout study ] [ Designated as safety issue: No ]|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00367354 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Respiratory Motion Analysis in Children With MRI|
|Official Title ICMJE||Respiratory Motion Analysis in Children for Improvement of MR (Magnetic Resonance) Imaging of Congenital Heart Disease|
The purpose of this project is to analyze the respiratory motion process as relevant in cardiac MRI imaging and apply the results for development of improved imaging methods and software correction. To accomplish this, we will develop an imaging protocol for monitoring respiratory motion.
The imaging protocol will be limited to less than five minutes of acquisition time so it may be performed as "piggyback" acquisition following clinically prescribed imaging studies on pediatric and adult cardiac MRI patients, but will also be applied to normal healthy volunteers.
Hypothesis Characterization of respiratory motion will help improve image quality by allowing optimized scan acquisition and retrospective correction of acquired data.
Cardiac magnetic resonance imaging (MRI) is used heavily in the research setting but its use is limited in clinical practice, the main reason being artifact (noise) from respiratory and cardiac motion. To counteract these sources of motion, many different applications have been applied. For cardiac motion, ECG (electrocardiogram) gating is widely used, while respiratory motion reduction uses methods of breath holding or respiratory gating techniques.
Patients will be recruited based on whether they are a normal healthy volunteer or a patient already receiving a routine cardiac MRI.
Normal Healthy Volunteers Patients will be recruited via a flyer posted in various locations at Emory University. The contents of this flyer will adhere strictly to Emory IRB Advertisement guidelines. Subjects will register by contacting Marijn Brunner, PhD, by email or telephone.
Patients already scheduled for a routine cardiac MRI The MRI technical specialist will review the laboratory schedule daily. Those who are already scheduled for a routine cardiac MRI will be approached by a study staff member in the Children's MRI Department. The patient will be asked if he/she would wish to enroll in this study. The patient will be requested to sign a consent prior to any study procedures being performed.
MRI image data will be collected by the prescribed protocol for respiratory monitoring. All MRI data will be acquired by standard FDA approved imaging methods. The image data will be transferred by network to the Pediatrics Imaging Research Laboratory where they will be stored on a password-protected computer and analyzed.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Observational Model: Case Control
Time Perspective: Prospective
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Non-Probability Sample|
35 healthy volunteers (21 years or older) and 25 cardiac MRI patients of different age groups.
|Condition ICMJE||Congenital Disorders|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||60|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
We wish to recruit cardiac patients from Children's Healthcare of Atlanta into five (5) different categories defined by the overall characteristics of breathing motion. The categories are:
We will recruit 10 - 35 healthy volunteer subjects for scans to define the MRI imaging protocol for respiratory motion monitoring. Healthy subjects are defined as those individuals who do not have a prior history of heart or lung disease nor are currently diagnosed with heart or lung disease. This information will be obtained verbally during the subject screening process.
|Accepts Healthy Volunteers||Yes|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00367354|
|Other Study ID Numbers ICMJE||763-2006|
|Has Data Monitoring Committee||No|
|Responsible Party||Dr. marijn Brummer, Emory University|
|Study Sponsor ICMJE||Emory University|
|Collaborators ICMJE||Not Provided|
|Information Provided By||Emory University|
|Verification Date||September 2008|
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