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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT03253835
Other study ID # CMR-12-LHD
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date November 21, 2013
Est. completion date December 31, 2027

Study information

Verified date November 2023
Source Medical University of Graz
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 150
Est. completion date December 31, 2027
Est. primary completion date December 31, 2025
Accepts healthy volunteers
Gender All
Age group 20 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Single Group Assignment


Locations

Country Name City State
Austria Medical Unitersity Graz, Department of Radiology, Division of General Radiology Graz Styria

Sponsors (2)

Lead Sponsor Collaborator
Medical University of Graz Anniversary Fund of the Oesterreichische Nationalbank

Country where clinical trial is conducted

Austria, 

References & Publications (2)

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. — View Citation

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 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 2 years
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