Sequence OptimizationNCT00557869
Optimization of Cardiac-MR Protocols
An observational study of Sequence Optimization and Protocol Optimization, run by Medical University of Graz at 1 site in Austria.
Trial summary
The aim of the present study is the optimization of various magnetic resonance (MR) investigation protocols of the heart and the lung without contrast agent application as well as the generation of normal values from cardiac MR images. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sequence Optimization, Protocol Optimization, Normal Values
- How many people
- 122 participants
- Where
- 1 siteAustria
- Study dates
- Oct 2002to Sep 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: healthy volunteers
Who may be able to join
- No history of cardiac or pulmonary diseases
Who cannot join
- MRI exclusion criteria
Trial locations and contacts
1 site in 1 country.
Austria1 site
Medical Unitersity Graz, Allgemeine Radiologische Diagnostik
Graz, Stmk, 8036
About this study
Official title: Optimization of Native Cardiac-MR Protocols
The aim of the present study is the optimization of various magnetic resonance (MR) investigation protocols of the heart and the lung without contrast agent application as well as the generation of normal values from cardiac MR images. One of the main problems in cardiac MR investigations is the strong dependence of the achieved image quality on optimal settings of sequence parameters and anatomical and physiological situations with special emphasis on phase-contrast imaging and other cine-techniques.
Read the detailed description
Time optimized and well organized MR protocols for the cardiac and lung investigations are evaluated on normal subjects with special respect to following topics:
- Localization: Definition of standardized anatomic imaging planes with special respect to the right ventricle.
- Morphological imaging: Optimization of spin-echo and gradient-echo sequences for various heart frequencies and breath-hold abilities. Investigation of the effect of various preparation pulses. Optimization of the signal-to-noise ratio for morphological cardiac imaging. Evaluation and optimization of various breathing and breath-hold (with and without navigator) ECG and pulse triggered sequences.
- Cardiac and lung function: Optimization of gradient-echo sequences for various heart frequencies and breath-hold abilities. Evaluation of pulse-triggered function analysis and optimization of free breathing protocols. Optimization of tagging techniques. Evaluation of the pulsatile flow in lung vessels. Acquisition of age depended normal data of cardiac and lung function.
- Coronary imaging: Definition of standardized anatomic imaging planes to monitor coronary arteries (single oblique, volume targeted). Optimization of acquisition window with respect to various heart frequencies. Evaluation of the influence of the position of the navigator and tracking factor on image quality. Optimization of a pulse triggered protocol. Evaluation of black-blood coronary imaging and visualization of the lumen and wall of coronary arteries.
- Phase contrast techniques: Optimization of imaging planes, time resolution and spatial resolution of flow measurements in the heart, in the vessels around the heart, lung vessels and coronary arteries. Evaluation of retrospective and prospective gating with respect to the heart frequency. Evaluation of normal values in 1-dimensional, 2-dimensional and 3-dimensional time resolved flow measurements.
- Single-Shot Imaging: Evaluation of signal intensity and stability of single shot techniques with and without preparation pulses. Optimization of real-time image acquisition.
- Parallel acquisition and breath-hold time optimization: Evaluation of impact of echo-sharing and parallel acquisition on image quality. Optimization of short-breath-hold protocols.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2007 (estimated)
- Study startOct 2002
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Sequence OptimizationStudies 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
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ursula Reiter, Medical University of Graz
- Investigators
- Gert Reiter, DI Dr., Principal investigator, Siemens Medical SolutionsUrsula Reiter, DI Dr., Principal investigator, Universitäts-Frauenklinik Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00557869
- Sponsor's protocol ID
- CMR-02-TECH-01
- Status last verified
- Dec 2011
- First submitted
- 13 Nov 2007
- Last updated
- 20 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Reiter G, Reiter U, Bergmann P, Rienmuller R. MR imaging-based port placement planning for totally endoscopic coronary artery bypass grafting. Interact Cardiovasc Thorac Surg. 2004 Jun;3(2):341-5. doi: 10.1016/j.icvts.2004.01.015.
PubMed 17670255Reiter G, Reiter U, Rienmuller R, Gagarina N, Ryabikin A. On the value of geometry-based models for left ventricular volumetry in magnetic resonance imaging and electron beam tomography: a Bland-Altman analysis. Eur J Radiol. 2004 Nov;52(2):110-8. doi: 10.1016/j.ejrad.2003.10.003.
PubMed 15489068Reiter G, Reiter U, Kovacs G, Kainz B, Schmidt K, Maier R, Olschewski H, Rienmueller R. Magnetic resonance-derived 3-dimensional blood flow patterns in the main pulmonary artery as a marker of pulmonary hypertension and a measure of elevated mean pulmonary arterial pressure. Circ Cardiovasc Imaging. 2008 Jul;1(1):23-30. doi: 10.1161/CIRCIMAGING.108.780247.
PubMed 19808511
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Native Cardiac-MR Protocols
- ClinicalTrials.gov ID
- NCT00557869
- Acronym / sponsor ID
- CMR-02-TECH-01
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- Oct 2002
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 14 Nov 2007 (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 aim of the present study is the optimization of various magnetic resonance (MR) investigation protocols of the heart and the lung without contrast agent application as well as the generation of normal values from cardiac MR images. One of the main problems in cardiac MR investigations is the strong dependence of the achieved image quality on optimal settings of sequence parameters and anatomical and physiological situations with special emphasis on phase-contrast imaging and other cine-techniques.
Detailed description
Time optimized and well organized MR protocols for the cardiac and lung investigations are evaluated on normal subjects with special respect to following topics:
- Localization: Definition of standardized anatomic imaging planes with special respect to the right ventricle.
- Morphological imaging: Optimization of spin-echo and gradient-echo sequences for various heart frequencies and breath-hold abilities. Investigation of the effect of various preparation pulses. Optimization of the signal-to-noise ratio for morphological cardiac imaging. Evaluation and optimization of various breathing and breath-hold (with and without navigator) ECG and pulse triggered sequences.
- Cardiac and lung function: Optimization of gradient-echo sequences for various heart frequencies and breath-hold abilities. Evaluation of pulse-triggered function analysis and optimization of free breathing protocols. Optimization of tagging techniques. Evaluation of the pulsatile flow in lung vessels. Acquisition of age depended normal data of cardiac and lung function.
- Coronary imaging: Definition of standardized anatomic imaging planes to monitor coronary arteries (single oblique, volume targeted). Optimization of acquisition window with respect to various heart frequencies. Evaluation of the influence of the position of the navigator and tracking factor on image quality. Optimization of a pulse triggered protocol. Evaluation of black-blood coronary imaging and visualization of the lumen and wall of coronary arteries.
- Phase contrast techniques: Optimization of imaging planes, time resolution and spatial resolution of flow measurements in the heart, in the vessels around the heart, lung vessels and coronary arteries. Evaluation of retrospective and prospective gating with respect to the heart frequency. Evaluation of normal values in 1-dimensional, 2-dimensional and 3-dimensional time resolved flow measurements.
- Single-Shot Imaging: Evaluation of signal intensity and stability of single shot techniques with and without preparation pulses. Optimization of real-time image acquisition.
- Parallel acquisition and breath-hold time optimization: Evaluation of impact of echo-sharing and parallel acquisition on image quality. Optimization of short-breath-hold protocols.
Study design
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- healthy volunteers
Key inclusion criteria (1 listed)
- No history of cardiac or pulmonary diseases
Key exclusion criteria (1 listed)
- MRI exclusion criteria
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 20 Dec 2011.
- Results publication: PubMed 17670255Reiter G, Reiter U, Bergmann P, Rienmuller R. MR imaging-based port placement planning for totally endoscopic coronary artery bypass grafting. Interact Cardiovasc Thorac Surg. 2004 Jun;3(2):341-5. doi: 10.1016/j.icvts.2004.01.015.
- Results publication: PubMed 15489068Reiter G, Reiter U, Rienmuller R, Gagarina N, Ryabikin A. On the value of geometry-based models for left ventricular volumetry in magnetic resonance imaging and electron beam tomography: a Bland-Altman analysis. Eur J Radiol. 2004 Nov;52(2):110-8. doi: 10.1016/j.ejrad.2003.10.003.
- Results publication: PubMed 19808511Reiter G, Reiter U, Kovacs G, Kainz B, Schmidt K, Maier R, Olschewski H, Rienmueller R. Magnetic resonance-derived 3-dimensional blood flow patterns in the main pulmonary artery as a marker of pulmonary hypertension and a measure of elevated mean pulmonary arterial pressure. Circ Cardiovasc Imaging. 2008 Jul;1(1):23-30. doi: 10.1161/CIRCIMAGING.108.780247.
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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.
Gert Reiter, DI Dr. principal investigator
Siemens Medical Solutions
Ursula Reiter, DI Dr. principal investigator
Universitäts-Frauenklinik Graz
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 Sequence Optimization and Protocol Optimization, run by Medical University of Graz at 1 site in Austria.
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 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 20 Dec 2011. 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 Austria. 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?
On the ClinicalTrials.gov record for NCT00557869, which also lists 3 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 20 Dec 2011.