Cardiac ChambersNCT00638664
Evaluation of the MRI in Measuring the Cardiac Chambers and Thoracic Great Vessels
An observational study of Cardiac Chambers, run by State University of New York - Upstate Medical University at 1 site in United States.
Trial summary
We are seeking volunteers to participate in a research study to determine the optimal imaging parameters for visualization of the heart and its great vessels so that errors in computer data analysis is minimized and clinical accuracy is maximized. Participation in this study will involve having an MRI of the heart. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiac Chambers
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- May 1995to May 2015
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Cardiology Clinic Center Watch Website
Who may be able to join
- Over the age of 18 years
- Able to understand and sign consent without surrogate signature
- Subject weight is within the 300lb limit of the MR scanning table
- Subject's bodily habitus allows the subject to fit within the MR bore
- Subject being able to lie quiescent for a period of up to 60 minutes in a supine position
- Subject would be able to hold breath at times for periods of 15-30 seconds
Who cannot join
- Subjects with pacemakers, TENS units, metallic prostheses, metal foreign bodies such as bullets, shrapnel, metallic slivers, shavings or foreign bodies
Trial locations and contacts
1 site in 1 country.
United States1 site
University Radiology Associates
Syracuse, New York, 13202
About this study
Official title: Optimized MRI Evaluation of Maximal Temporal and Spatial Measurability of the Cardiac Chambers and Thoracic Great Vessels. A Comparison of MR Acquisition Pulse Sequences.
We are seeking volunteers to participate in a research study to determine the optimal imaging parameters for visualization of the heart and its great vessels so that errors in computer data analysis is minimized and clinical accuracy is maximized.
Participation in this study will involve having an MRI of the heart. This study will allow us to determine the ability to measure the volumes of your heart chambers in both the left and right side of your heart without using any aggressive (invasive) technique or the use of ionizing radiation (x-rays or gamma rays). The study will also allow us to measure changes in the cardiac chamber volumes during the cardiac cycle and determine whether this can be done rapidly and accurately. The study will also allow us to determine whether this technique can be used for routine clinical use.
Read the detailed description
The ability to obtain accurate cyclical functional information of the cardiac chambers plays a continuing important clinical diagnostic role in the evaluation and monitoring of patients with a wide range of cardiac pathologies, including those embarking on or continuing cardiotoxic chemotherapeutic regimes, as well as patients with lung disease.
The current imaging modalities used for non-invasive imaging of the heart include echocardiography and radionuclide ventriculography. Echocardiographic evaluation of cardiac function is primarily limited to the left ventricle and functional measurements are based on volumetric estimates in turn based usually on geometric assumptions. That is, the volume calculation is based on a limited number of non orthogonal linear measurements assuming a regular (non complex) chamber morphology. This study technique provides no biologic hazard to the patient.
Radionuclide ventriculography does allow for 3D cardiac data acquisition and theoretical evaluation of biventricular function. However, the technique does not provide the same degree of spatial resolution that echocardiography can provide. Radionuclide ventriculography is a commonly accepted diagnostic procedure but does involve use of ionizing radiation.
Magnetic Resonance imaging techniques (of the heart) allows relatively high resolution cross sectional imaging. For example a 512X512 matrix over a 40cm field of view provides in plane resolution better that 1mm. No assumptions are made in regard chamber cross sectional area and hence volume morphology. The slice thickness is determined in advance and may be in the range of 1-10mm. MR data ca be acquired sequentially throughout the cardiac cycle and thus provide a time varying 3D map of the cardiac chambers and related structures during the cardiac cycle.
- Conditions
- Cardiac Chambers
- Keywords
- conventional pulse sequences for MR, cardiac chambers and walls, cardio-thoracic vasculature, the great vessels, coronary vasculature, cardiac, great vessels
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2008 (estimated)
- Study startMay 1995
- Primary completionMar 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ChambersStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York - Upstate Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Feiglin, State University of New York - Upstate Medical University
- Investigators
- David Feiglin, MD, Principal investigator, SUNY Upstate MU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00638664
- Sponsor's protocol ID
- SUNYUMU 3149
- Status last verified
- Dec 2023
- First submitted
- 1 Feb 2008
- Last updated
- 21 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimized MRI Evaluation of Maximal Temporal and Spatial Measurability of the Cardiac Chambers and Thoracic Great Vessels. A Comparison of MR Acquisition Pulse Sequences.
- ClinicalTrials.gov ID
- NCT00638664
- Acronym / sponsor ID
- SUNYUMU 3149
- Conditions
- Cardiac Chambers
- Keywords
- conventional pulse sequences for MR, cardiac chambers and walls, cardio-thoracic vasculature, the great vessels, coronary vasculature, cardiac, great vessels
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- State University of New York - Upstate Medical UniversityUniversity, hospital or other
- Study start
- May 1995 (actual)
- Primary completion
- Mar 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 19 Mar 2008 (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.
We are seeking volunteers to participate in a research study to determine the optimal imaging parameters for visualization of the heart and its great vessels so that errors in computer data analysis is minimized and clinical accuracy is maximized.
Participation in this study will involve having an MRI of the heart. This study will allow us to determine the ability to measure the volumes of your heart chambers in both the left and right side of your heart without using any aggressive (invasive) technique or the use of ionizing radiation (x-rays or gamma rays). The study will also allow us to measure changes in the cardiac chamber volumes during the cardiac cycle and determine whether this can be done rapidly and accurately. The study will also allow us to determine whether this technique can be used for routine clinical use.
Detailed description
The ability to obtain accurate cyclical functional information of the cardiac chambers plays a continuing important clinical diagnostic role in the evaluation and monitoring of patients with a wide range of cardiac pathologies, including those embarking on or continuing cardiotoxic chemotherapeutic regimes, as well as patients with lung disease.
The current imaging modalities used for non-invasive imaging of the heart include echocardiography and radionuclide ventriculography. Echocardiographic evaluation of cardiac function is primarily limited to the left ventricle and functional measurements are based on volumetric estimates in turn based usually on geometric assumptions. That is, the volume calculation is based on a limited number of non orthogonal linear measurements assuming a regular (non complex) chamber morphology. This study technique provides no biologic hazard to the patient.
Radionuclide ventriculography does allow for 3D cardiac data acquisition and theoretical evaluation of biventricular function. However, the technique does not provide the same degree of spatial resolution that echocardiography can provide. Radionuclide ventriculography is a commonly accepted diagnostic procedure but does involve use of ionizing radiation.
Magnetic Resonance imaging techniques (of the heart) allows relatively high resolution cross sectional imaging. For example a 512X512 matrix over a 40cm field of view provides in plane resolution better that 1mm. No assumptions are made in regard chamber cross sectional area and hence volume morphology. The slice thickness is determined in advance and may be in the range of 1-10mm. MR data ca be acquired sequentially throughout the cardiac cycle and thus provide a time varying 3D map of the cardiac chambers and related structures during the cardiac cycle.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Cardiology Clinic Center Watch Website
Key inclusion criteria (6 listed)
- Over the age of 18 years
- Able to understand and sign consent without surrogate signature
- Subject weight is within the 300lb limit of the MR scanning table
- Subject's bodily habitus allows the subject to fit within the MR bore
- Subject being able to lie quiescent for a period of up to 60 minutes in a supine position
Key exclusion criteria (1 listed)
- Subjects with pacemakers, TENS units, metallic prostheses, metal foreign bodies such as bullets, shrapnel, metallic slivers, shavings or foreign bodies
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
Not reported in the source record.
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 21 Dec 2023.
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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.
David Feiglin, MD principal investigator
SUNY Upstate MU
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 Cardiac Chambers, run by State University of New York - Upstate Medical 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 6 inclusion and 1 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 21 Dec 2023. 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.
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 21 Dec 2023.