- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03253835
Cardiac Blood Flow Patterns Associated With Left Ventricular Myocardial Damage (CMR-LHD)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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-
Styria
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Graz, Styria, Austria, 8036
- Medical Unitersity Graz, Department of Radiology, Division of General Radiology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Myocardial Injury
patients with myocardial injuries due to ischemic heart disease, patients with myocardial injuries due to non-ischemic heart disease.
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No Myocardial Injury
subjects without myocardial injuries with normal cardiac function subjects without myocardial injuries with altered cardiac function
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Myocardial pathology-associated blood flow patterns in the heart and surrounding great vessels
Time Frame: 2 years
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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
|
2 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Michael Fuchsjäger, Univ.-Prof., Medical Universtiy of Graz
- Principal Investigator: Ursula Reiter, PD DI Dr., Medical Universtiy of Graz
Publications and helpful links
General Publications
- Krauter 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CMR-12-LHD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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