CardiomyopathiesCMR-LHDNCT03253835
Cardiac Blood Flow Patterns Associated With Left Ventricular Myocardial Damage
An observational study of Cardiomyopathies and Myocardial Injury, run by Medical University of Graz at 1 site in Austria.
Trial summary
Various factors affect the performance of the heart: The contractile properties of myocardial muscle cells are the fundamental devices for translating tension-generation and shortening of the cardiac muscle into pressure-generation and blood volume ejection from the heart into the body. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Cardiomyopathies, Myocardial Injury, Healthy
- What is being tested?
- Single Group Assignment
- How many people
- 150 participants
- Where
- 1 siteAustria
- Study dates
- 21 Nov 2013to 31 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 20 to 80 years
- All sexes
- Adult, Older adult
Study population: Patients referred to CMR investigation. If suitable and inclusion criteria are met, the patient will be asked if she/he is interested in participating in this study. Participation means, that aside from the respective routine CMR protocol, additional images will be taken within the investigation resulting in 15-20 minutes extra investigation time.
Who may be able to join
- patients age 20-80 years,
- patients with and without ischemic or non-ischemic myocardial injuries scheduled for routine cardiac magnetic resonance imaging,
- ability to hold the breath,
- ability to give informed consent
Who cannot join
- patients with metal devices or other magnetic material in or on the subjects body which will be hazardous for magnetic resonance investigation (e.g. heart pace-maker, brain aneurysm clip, nerve stimulators, electrodes, penile implants, colored 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),
- patients with tendency toward claustrophobia,
- hemodynamically unstable patients,
- patients with (major) arrhythmia
- pregnancy,
- impaired kidney function indicated by creatin clearance lower than 60 ml/min (creatin clearance will be calculated according to Cockroft-Gault formula)
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
Medical Unitersity Graz, Department of Radiology, Division of General Radiology
Graz, Styria, 8036
About this study
Official title: Cardiac Blood Flow Patterns Associated With Regional and Global Left Ventricular Myocardial Damage: an Explorative Study by Cardiac Magnetic Resonance
Various factors affect the performance of the heart: The contractile properties of myocardial muscle cells are the fundamental devices for translating tension-generation and shortening of the cardiac muscle into pressure-generation and blood volume ejection from the heart into the body. On the other hand, the performance of heart can be analyzed with respect to input and output of blood to/from the hollow cardiac muscle and evaluated in terms of the performance of a pump: With every heartbeat blood is sucked from a low-pressure system (veins) and pumped to the arterial high-pressure system via one-way valves, whereas efficiency, ejected blood volume, blood flow and pressures are linked by hemodynamic laws.
Cardiac magnetic resonance (CMR) is the "gold standard technique" to determine cardiac function and muscle mass, as well as for non-invasive diagnosis of myocardial necrosis/fibrosis. Furthermore, new CMR imaging techniques enabling the measurement of myocardial magnetic relaxation times for characterization of myocardial morphology and the acquisition of time-resolved, three-dimensional blood flow velocity fields in the heart and surrounding vessels, represent promising tools for the evaluation of the interaction between myocardial morphology and cardiac function.
Aim of this explorative study is to 1. identify myocardial pathology-associated blood flow patterns in the heart and surrounding great vessels, and 2. correlate characteristic blood flow patterns in the heat (existence of vortices, vorticity, vortex formation, propagation dynamics …) with myocardial injuries.
- Conditions
- Cardiomyopathies, Myocardial Injury, Healthy
- Being tested
- Single Group Assignment
- Medical subject headings
- Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single Group AssignmentDiagnostic test
| Study group | Role | What they receive |
|---|---|---|
| Myocardial Injury | patients with myocardial injuries due to ischemic heart disease, patients with myocardial injuries due to non-ischemic heart disease. Receives: Diagnostic Test: Single Group Assignment | |
| No Myocardial Injury | subjects without myocardial injuries with normal cardiac function subjects without myocardial injuries with altered cardiac function Receives: Diagnostic Test: Single Group Assignment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial pathology-associated blood flow patterns in the heart and surrounding great vessels
Morphologic, functional and blood flow CMR parameters will be evaluated with different techniques. Cardiac blood flow pattern parameters will be correlated with myocardial injury derived non-invasively from late gadolinium enhancement
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2017
- Study start21 Nov 2013
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2027 (estimated)
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 CardiomyopathiesStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Collaborators
- Anniversary Fund of the Oesterreichische Nationalbank
- Responsible party
- Principal investigator, Ursula Reiter, Medical University of Graz
- Investigators
- Michael Fuchsjäger, Univ.-Prof., Study chair, Medical Universtiy of GrazUrsula Reiter, PD DI Dr., Principal investigator, Medical Universtiy of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03253835
- Sponsor's protocol ID
- CMR-12-LHD
- Acronym
- CMR-LHD
- Status last verified
- Feb 2025
- First submitted
- 16 Aug 2017
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Krauter C, Reiter U, Reiter C, Nizhnikava V, Schmidt A, Stollberger R, Fuchsjager M, Reiter G. Impact of the Choice of Native T1 in Pixelwise Myocardial Blood Flow Quantification. J Magn Reson Imaging. 2021 Mar;53(3):755-765. doi: 10.1002/jmri.27375. Epub 2020 Oct 8.
PubMed 33034120Krauter 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 G, Krauter C, Kolesnik E, Greiser A, Scherr D, Schmidt A, Fuchsjager M, Reiter U. Impact of the evaluation method on 4D flow-derived diastolic transmitral and myocardial peak velocities: Comparison with echocardiography. Eur J Radiol. 2024 Jan;170:111247. doi: 10.1016/j.ejrad.2023.111247. Epub 2023 Dec 5.
PubMed 38071909
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
- Cardiac Blood Flow Patterns Associated With Regional and Global Left Ventricular Myocardial Damage: an Explorative Study by Cardiac Magnetic Resonance
- ClinicalTrials.gov ID
- NCT03253835
- Acronym / sponsor ID
- CMR-LHD / CMR-12-LHD
- Conditions
- Cardiomyopathies, Myocardial Injury, Healthy
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Collaborators
- Anniversary Fund of the Oesterreichische Nationalbank
- Study start
- 21 Nov 2013 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 18 Aug 2017 (actual)
- 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.
Various factors affect the performance of the heart: The contractile properties of myocardial muscle cells are the fundamental devices for translating tension-generation and shortening of the cardiac muscle into pressure-generation and blood volume ejection from the heart into the body. On the other hand, the performance of heart can be analyzed with respect to input and output of blood to/from the hollow cardiac muscle and evaluated in terms of the performance of a pump: With every heartbeat blood is sucked from a low-pressure system (veins) and pumped to the arterial high-pressure system via one-way valves, whereas efficiency, ejected blood volume, blood flow and pressures are linked by hemodynamic laws.
Cardiac magnetic resonance (CMR) is the "gold standard technique" to determine cardiac function and muscle mass, as well as for non-invasive diagnosis of myocardial necrosis/fibrosis. Furthermore, new CMR imaging techniques enabling the measurement of myocardial magnetic relaxation times for characterization of myocardial morphology and the acquisition of time-resolved, three-dimensional blood flow velocity fields in the heart and surrounding vessels, represent promising tools for the evaluation of the interaction between myocardial morphology and cardiac function.
Aim of this explorative study is to 1. identify myocardial pathology-associated blood flow patterns in the heart and surrounding great vessels, and 2. correlate characteristic blood flow patterns in the heat (existence of vortices, vorticity, vortex formation, propagation dynamics …) with myocardial injuries.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Myocardial Injury | – | Diagnostic Test: Single Group Assignmentpatients with myocardial injuries due to ischemic heart disease, patients with myocardial injuries due to non-ischemic heart disease. |
| No Myocardial Injury | – | Diagnostic Test: Single Group Assignmentsubjects without myocardial injuries with normal cardiac function subjects without myocardial injuries with altered cardiac function |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients referred to CMR investigation. If suitable and inclusion criteria are met, the patient will be asked if she/he is interested in participating in this study. Participation means, that aside from the respective routine CMR protocol, additional images will be taken within the investigation resulting in 15-20 minutes extra investigation time.
Key inclusion criteria (4 listed)
- patients age 20-80 years,
- patients with and without ischemic or non-ischemic myocardial injuries scheduled for routine cardiac magnetic resonance imaging,
- ability to hold the breath,
- ability to give informed consent
Key exclusion criteria (6 listed)
- patients with metal devices or other magnetic material in or on the subjects body which will be hazardous for magnetic resonance investigation (e.g. heart pace-maker, brain aneurysm clip, nerve stimulators, electrodes, penile implants, colored 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),
- patients with tendency toward claustrophobia,
- hemodynamically unstable patients,
- patients with (major) arrhythmia
- pregnancy,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single Group Assignment | Diagnostic test | Myocardial Injury, No Myocardial Injury |
Primary outcome
Myocardial pathology-associated blood flow patterns in the heart and surrounding great vessels
Time frame: 2 years
Morphologic, functional and blood flow CMR parameters will be evaluated with different techniques. Cardiac blood flow pattern parameters will be correlated with myocardial injury derived non-invasively from late gadolinium enhancement
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 33034120Krauter C, Reiter U, Reiter C, Nizhnikava V, Schmidt A, Stollberger R, Fuchsjager M, Reiter G. Impact of the Choice of Native T1 in Pixelwise Myocardial Blood Flow Quantification. J Magn Reson Imaging. 2021 Mar;53(3):755-765. doi: 10.1002/jmri.27375. Epub 2020 Oct 8.
- 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 38071909Reiter C, Reiter G, Krauter C, Kolesnik E, Greiser A, Scherr D, Schmidt A, Fuchsjager M, Reiter U. Impact of the evaluation method on 4D flow-derived diastolic transmitral and myocardial peak velocities: Comparison with echocardiography. Eur J Radiol. 2024 Jan;170:111247. doi: 10.1016/j.ejrad.2023.111247. Epub 2023 Dec 5.
- Individual participant dataSharing planned: No
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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.
Michael Fuchsjäger, Univ.-Prof. study chair
Medical Universtiy of Graz
Ursula Reiter, PD DI Dr. principal investigator
Medical Universtiy of 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 Cardiomyopathies and Myocardial Injury, 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 4 inclusion and 6 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: enrolling by invitation, 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?
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?
Myocardial pathology-associated blood flow patterns in the heart and surrounding great vessels (time frame: 2 years). 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 NCT03253835, 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 12 Feb 2025.