Congenital DisordersNCT00367354
Respiratory Motion Analysis in Children With MRI
An observational study of Congenital Disorders, run by Emory University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Congenital Disorders
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to Jul 2011
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 35 healthy volunteers (21 years or older) and 25 cardiac MRI patients of different age groups.
Who may be able to join
- We will recruit two groups of patients - 35 healthy volunteers (21 years or older) and 25 cardiac MRI patients of different age groups.
- 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:
- neonates/infants (shallow belly breathing)
- young children (unable to do controlled breathing or breath-holding on command, up to approximately 7 years of age)
- older children capable of controlled breathing/breath-holding on command (approximately 8-12 years of age)
- teenagers/adolescents/young adults (ages 13 through 17)
- adults (18 and older) These categories may be adjusted or modified during the project as deemed appropriate based on the analysis results.
- 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.
Who cannot join
- No exclusion criteria will be placed on any sub-population based on age, gender or race other than the patient not freely giving written informed consent or having a history or current diagnosis of heart or lung disease. However, the normal exclusion criteria for MRI exams will still be adhered to:
- subjects with pacemakers, medical implants, aneurysm clips, or imbedded metal fragments will be excluded because of potential effects of the magnetic field
- women who are pregnant or who may be pregnant will be excluded because of the potential of a high level of RF power deposition on the fetus
- subjects who may experience claustrophobia will be excluded because of their inability to remain in the magnet for the time required to complete the exam
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Congenital Disorders
- Keywords
- Imaging Technology, Cardiology
- Medical subject headings
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities
What is being measured
The primary outcome is the main question the study is designed to answer.
cardiac motion reduction in cardiac MRI images
Measured: throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2006 (estimated)
- Study startAug 2006
- Primary completionJun 2010
- Study completionJul 2011
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital DisordersStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William T. Mahle, MD, Emory University
- Investigators
- William Mahle, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00367354
- Sponsor's protocol ID
- IRB00041134
- Status last verified
- Dec 2014
- First submitted
- 18 Aug 2006
- Last updated
- 9 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Motion Analysis in Children for Improvement of MR (Magnetic Resonance) Imaging of Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT00367354
- Acronym / sponsor ID
- IRB00041134
- Conditions
- Congenital Disorders
- Keywords
- Imaging Technology, Cardiology
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Lack of funding
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Aug 2006
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 22 Aug 2006 (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.
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.
Detailed description
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 35 healthy volunteers (21 years or older) and 25 cardiac MRI patients of different age groups.
Key inclusion criteria (8 listed)
- We will recruit two groups of patients - 35 healthy volunteers (21 years or older) and 25 cardiac MRI patients of different age groups.
- 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:
- neonates/infants (shallow belly breathing)
- young children (unable to do controlled breathing or breath-holding on command, up to approximately 7 years of age)
- older children capable of controlled breathing/breath-holding on command (approximately 8-12 years of age)
Key exclusion criteria (4 listed)
- No exclusion criteria will be placed on any sub-population based on age, gender or race other than the patient not freely giving written informed consent or having a history or current diagnosis of heart or lung disease. However, the normal exclusion criteria for MRI exams will still be adhered to:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
cardiac motion reduction in cardiac MRI images
Time frame: throughout study
Results and safety
The study was stopped early (reason given: Lack of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2014.
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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.
William Mahle principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Disorders, run by Emory University 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 8 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: stopped early, as of the sponsor's last update on 9 Dec 2014. 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 was stopped early (reason given: Lack of funding). Results are not available in the source record.
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?
cardiac motion reduction in cardiac MRI images (time frame: throughout study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Dec 2014; AzTrials last refreshed its copy on 1 Nov 2026.