Clinical trial NCT01728597: Non-contrast Enhanced Cardiac Magnetic Resonance Normal Values and Imaging Protocols
Official title: Optimization of Non-contrast Enhanced 1.5 Tesla and 3 Tesla Cardiac Magnetic Resonance Imaging Techniques and Acquisition of Normal Values
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Healthy
Keywords: no history of cardiovascular diseases
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
Collaborators: name: Amt der Steiermärkischen Landesregierung, Abteilung 3
First posted: 2012-11-20
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy volunteers

Brief 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 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).


Eligibility criteria: Inclusion Criteria:

* No history of cardiac or pulmonary diseases
* ability to give informed consent

Exclusion Criteria:

* 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.

Primary outcomes:
measure: cardiac volumes
timeFrame: up to 1 week
measure: cardiac performance
timeFrame: up to 1 week
measure: cardiac muscle mass
timeFrame: up to 1 week
measure: coronary artery anatomy
timeFrame: up to 1 week
measure: blood flow velocity
timeFrame: up to 1 week
measure: blood flow vorticity
timeFrame: up to 1 week
measure: blood flow timing
timeFrame: up to 1 week
measure: magnetic relaxation times
timeFrame: up to 1 week
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 Unitersity Graz, Department of Radiology, Division of General Radiology
name: Ursula Reiter, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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 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.
citation: Reiter 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.
citation: Gillette 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.