Clinical trial NCT03253835: Cardiac Blood Flow Patterns Associated With Left Ventricular Myocardial Damage
Official title: Cardiac Blood Flow Patterns Associated With Regional and Global Left Ventricular Myocardial Damage: an Explorative Study by Cardiac Magnetic Resonance
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Cardiomyopathies
Myocardial Injury
Healthy
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
Collaborators: name: Anniversary Fund of the Oesterreichische Nationalbank
First posted: 2017-08-18
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Myocardial pathology-associated blood flow patterns in the heart and surrounding great vessels
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical Unitersity Graz, Department of Radiology, Division of General Radiology
state: Styria
Study officials:
affiliation: Medical Universtiy of Graz
name: Michael Fuchsjäger, Univ.-Prof.
role: STUDY_CHAIR
affiliation: Medical Universtiy of Graz
name: Ursula Reiter, PD DI Dr.
role: PRINCIPAL_INVESTIGATOR
References:
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 2020 Oct 8.
citation: 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.
citation: Reiter 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.