HealthyCMR-TECHNCT01728597
Non-contrast Enhanced Cardiac Magnetic Resonance Normal Values and Imaging Protocols
An observational study of Healthy, run by Medical University of Graz at 1 site in Austria.
Trial summary
One of the main problems in cardiac magnetic resonance (MR) investigations is the strong dependence of the achieved image quality on optimal settings of sequence parameters and anatomical and physiological situations and it is well known that the diagnostic impact of cardiac MR investigations crucially depends on the… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 200 participants
- Where
- 1 siteAustria
- Study dates
- Dec 2011to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: healthy volunteers
Who may be able to join
- No history of cardiac or pulmonary diseases
- ability to give informed consent
Who cannot join
- General MR exclusion criteria eg. patients with metal devices or other magnetic material in or on the subjects body which will be hazardous for MR investigation (e.g. heart pace-maker, brain aneurysm clip, nerve stimulators, electrodes, penile implants, coloured contact lenses, patch to deliver medications through the skin, any metal implants as rods, joints, plates, pins, screws, nails or clips, embolization coil, or any metal fragments or shrapnel in the body),
- pregnancy,
- claustrophobia.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
Medical Unitersity Graz, Department of Radiology, Division of General Radiology
Graz, Styria, 8036
Michael Fuchsjäger, Prof. Dr., +43-316-385 ext. 2411, michael.fuchsjaeger@medunigraz.at
Ursula Reiter, PhD, +43-316-385 ext. 83347, ursula.reiter@klinikum-graz.at
About this study
Official title: Optimization of Non-contrast Enhanced 1.5 Tesla and 3 Tesla Cardiac Magnetic Resonance Imaging Techniques and Acquisition of Normal Values
One of the main problems in cardiac magnetic resonance (MR) investigations is the strong dependence of the achieved image quality on optimal settings of sequence parameters and anatomical and physiological situations and it is well known that the diagnostic impact of cardiac MR investigations crucially depends on the adaption of imaging protocols to patients' state and ability to cooperate.
The aim of the present study is the evaluation and optimization of various 1.5 Tesla and 3 Tesla cardiac MR investigation protocols without application of contrast agent as well as the acquisition of normal values for new cardiac MR images techniques:
- normal myocardial morphology: T1-, T2- and T2*-weighted imaging and acquisition of normal values of magnetic relaxation times (sequence- and protocol dependent),
- normal cardiac function: systolic and diastolic function (sequence- and protocol dependent),
- cardiac anatomy and coronary artery imaging: feasibility to evaluate length, diameter and blood flow (sequence- and protocol dependent),
- normal blood flow topologies in the heart and the surrounding great vessels: 2D- and 3D blood flow imaging and evaluation techniques (sequence- and protocol dependent).
- Conditions
- Healthy
- Keywords
- no history of cardiovascular diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| healthy volunteers | MR compliant volunteers with no history of cardiovascular diseases |
What is being measured
The primary outcome is the main question the study is designed to answer.
cardiac volumes
volumes of cardiac chambers in the cardiac cycle [ml], sequence- and protocol dependent
Measured: up to 1 week
cardiac performance
ejection fraction of cardiac chambers [%], sequence- and protocol dependent
Measured: up to 1 week
cardiac muscle mass
systolic and end-diastolic mass of cardiac chambers [g], sequence- and protocol dependent
Measured: up to 1 week
coronary artery anatomy
length and diameter [mm], sequence-, and protocol dependent
Measured: up to 1 week
blood flow velocity
maximum, minimum and average velocity [cm/s], sequence-, and protocol dependent
Measured: up to 1 week
blood flow vorticity
number of vortices of blood flow in the heart and surrounding great vessels, sequence and protocol dependent
Measured: up to 1 week
blood flow timing
time points of characteristic blood flow patterns in the heart and surrounding great vessels in the cardiac cycle [ms], sequence-, and protocol dependent
Measured: up to 1 week
magnetic relaxation times
systolic and diastolic T1, T2, T2* [ms], sequence- and protocol dependent
Measured: up to 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2012 (estimated)
- Study startDec 2011
- Primary completionDec 2025 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe 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
- Other
- Time perspective
- Other
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Collaborators
- Amt der Steiermärkischen Landesregierung, Abteilung 3
- Responsible party
- Principal investigator, Ursula Reiter, Medical University of Graz
- Investigators
- Ursula Reiter, PhD, Principal investigator, Medical Unitersity Graz, Department of Radiology, Division of General Radiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01728597
- Sponsor's protocol ID
- CMR-12-TECH-02
- Acronym
- CMR-TECH
- Status last verified
- Feb 2025
- First submitted
- 3 Nov 2012
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Reiter U, Reiter G, Dorr K, Greiser A, Maderthaner R, Fuchsjager M. Normal diastolic and systolic myocardial T1 values at 1.5-T MR imaging: correlations and blood normalization. Radiology. 2014 May;271(2):365-72. doi: 10.1148/radiol.13131225. Epub 2013 Dec 6.
PubMed 24475837Krauter C, Reiter U, Reiter C, Nizhnikava V, Masana M, Schmidt A, Fuchsjager M, Stollberger R, Reiter G. Automated mitral valve vortex ring extraction from 4D-flow MRI. Magn Reson Med. 2020 Dec;84(6):3396-3408. doi: 10.1002/mrm.28361. Epub 2020 Jun 18.
PubMed 32557819Reiter C, Reiter U, Krauter C, Nizhnikava V, Greiser A, Scherr D, Schmidt A, Fuchsjager M, Reiter G. Differences in left ventricular and left atrial function assessed during breath-holding and breathing. Eur J Radiol. 2021 Aug;141:109756. doi: 10.1016/j.ejrad.2021.109756. Epub 2021 May 7.
PubMed 34023727Reiter C, Reiter G, Krauter C, Scherr D, Schmidt A, Fuchsjager M, Reiter U. Evaluation of left ventricular and left atrial volumetric function from native MR multislice 4D flow magnitude data. Eur Radiol. 2024 Feb;34(2):981-993. doi: 10.1007/s00330-023-10017-3. Epub 2023 Aug 15.
PubMed 37580598Gillette K, Gsell MAF, Prassl AJ, Karabelas E, Reiter U, Reiter G, Grandits T, Payer C, Stern D, Urschler M, Bayer JD, Augustin CM, Neic A, Pock T, Vigmond EJ, Plank G. A Framework for the generation of digital twins of cardiac electrophysiology from clinical 12-leads ECGs. Med Image Anal. 2021 Jul;71:102080. doi: 10.1016/j.media.2021.102080. Epub 2021 Apr 22.
PubMed 33975097
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Non-contrast Enhanced 1.5 Tesla and 3 Tesla Cardiac Magnetic Resonance Imaging Techniques and Acquisition of Normal Values
- ClinicalTrials.gov ID
- NCT01728597
- Acronym / sponsor ID
- CMR-TECH / CMR-12-TECH-02
- Conditions
- Healthy
- Keywords
- no history of cardiovascular diseases
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Collaborators
- Amt der Steiermärkischen Landesregierung, Abteilung 3
- Study start
- Dec 2011
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 20 Nov 2012 (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.
One of the main problems in cardiac magnetic resonance (MR) investigations is the strong dependence of the achieved image quality on optimal settings of sequence parameters and anatomical and physiological situations and it is well known that the diagnostic impact of cardiac MR investigations crucially depends on the adaption of imaging protocols to patients' state and ability to cooperate.
The aim of the present study is the evaluation and optimization of various 1.5 Tesla and 3 Tesla cardiac MR investigation protocols without application of contrast agent as well as the acquisition of normal values for new cardiac MR images techniques:
- normal myocardial morphology: T1-, T2- and T2*-weighted imaging and acquisition of normal values of magnetic relaxation times (sequence- and protocol dependent),
- normal cardiac function: systolic and diastolic function (sequence- and protocol dependent),
- cardiac anatomy and coronary artery imaging: feasibility to evaluate length, diameter and blood flow (sequence- and protocol dependent),
- normal blood flow topologies in the heart and the surrounding great vessels: 2D- and 3D blood flow imaging and evaluation techniques (sequence- and protocol dependent).
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| healthy volunteers | – | –MR compliant volunteers with no history of cardiovascular diseases |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- healthy volunteers
Key inclusion criteria (2 listed)
- No history of cardiac or pulmonary diseases
- ability to give informed consent
Key exclusion criteria (3 listed)
- General MR exclusion criteria eg. patients with metal devices or other magnetic material in or on the subjects body which will be hazardous for MR investigation (e.g. heart pace-maker, brain aneurysm clip, nerve stimulators, electrodes, penile implants, coloured contact lenses, patch to deliver medications through the skin, any metal implants as rods, joints, plates, pins, screws, nails or clips, embolization coil, or any metal fragments or shrapnel in the body),
- pregnancy,
- claustrophobia.
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 volumes
Time frame: up to 1 week
volumes of cardiac chambers in the cardiac cycle [ml], sequence- and protocol dependent
cardiac performance
Time frame: up to 1 week
ejection fraction of cardiac chambers [%], sequence- and protocol dependent
cardiac muscle mass
Time frame: up to 1 week
systolic and end-diastolic mass of cardiac chambers [g], sequence- and protocol dependent
coronary artery anatomy
Time frame: up to 1 week
length and diameter [mm], sequence-, and protocol dependent
blood flow velocity
Time frame: up to 1 week
maximum, minimum and average velocity [cm/s], sequence-, and protocol dependent
blood flow vorticity
Time frame: up to 1 week
number of vortices of blood flow in the heart and surrounding great vessels, sequence and protocol dependent
blood flow timing
Time frame: up to 1 week
time points of characteristic blood flow patterns in the heart and surrounding great vessels in the cardiac cycle [ms], sequence-, and protocol dependent
magnetic relaxation times
Time frame: up to 1 week
systolic and diastolic T1, T2, T2* [ms], sequence- and protocol dependent
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- Results publication: PubMed 24475837Reiter U, Reiter G, Dorr K, Greiser A, Maderthaner R, Fuchsjager M. Normal diastolic and systolic myocardial T1 values at 1.5-T MR imaging: correlations and blood normalization. Radiology. 2014 May;271(2):365-72. doi: 10.1148/radiol.13131225. Epub 2013 Dec 6.
- Results publication: PubMed 32557819Krauter C, Reiter U, Reiter C, Nizhnikava V, Masana M, Schmidt A, Fuchsjager M, Stollberger R, Reiter G. Automated mitral valve vortex ring extraction from 4D-flow MRI. Magn Reson Med. 2020 Dec;84(6):3396-3408. doi: 10.1002/mrm.28361. Epub 2020 Jun 18.
- Results publication: PubMed 34023727Reiter C, Reiter U, Krauter C, Nizhnikava V, Greiser A, Scherr D, Schmidt A, Fuchsjager M, Reiter G. Differences in left ventricular and left atrial function assessed during breath-holding and breathing. Eur J Radiol. 2021 Aug;141:109756. doi: 10.1016/j.ejrad.2021.109756. Epub 2021 May 7.
- Results publication: PubMed 37580598Reiter C, Reiter G, Krauter C, Scherr D, Schmidt A, Fuchsjager M, Reiter U. Evaluation of left ventricular and left atrial volumetric function from native MR multislice 4D flow magnitude data. Eur Radiol. 2024 Feb;34(2):981-993. doi: 10.1007/s00330-023-10017-3. Epub 2023 Aug 15.
- Results publication: PubMed 33975097Gillette K, Gsell MAF, Prassl AJ, Karabelas E, Reiter U, Reiter G, Grandits T, Payer C, Stern D, Urschler M, Bayer JD, Augustin CM, Neic A, Pock T, Vigmond EJ, Plank G. A Framework for the generation of digital twins of cardiac electrophysiology from clinical 12-leads ECGs. Med Image Anal. 2021 Jul;71:102080. doi: 10.1016/j.media.2021.102080. Epub 2021 Apr 22.
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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.
Ursula Reiter, PhD principal investigator
Medical Unitersity Graz, Department of Radiology, Division of General Radiology
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 Healthy, 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 2 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 12 Feb 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ursula Reiter, PhD (+43-316-385 ext. 83347, ursula.reiter@klinikum-graz.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cardiac volumes (time frame: up to 1 week). The study lists 8 primary outcomes in all. 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 NCT01728597, which also lists 5 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 12 Feb 2025.