Non-contrast Enhanced Cardiac Magnetic Resonance Normal Values and Imaging Protocols

Healthy Clinical Trial

— CMR-TECH  

Official title:

Optimization of Non-contrast Enhanced 1.5 Tesla and 3 Tesla Cardiac Magnetic Resonance Imaging Techniques and Acquisition of Normal Values

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01728597
• Other study ID #: CMR-12-TECH-02
• Status: Recruiting
• Start date: December 2011
• Est. completion date: December 2027

Study information

• Verified date: November 2023
• Source: Medical University of Graz
• Contact: Ursula Reiter, PhD
• Phone: +43-316-385
• Email: ursula.reiter[@]klinikum-graz.at
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2027
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

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	Amt der Steiermärkischen Landesregierung, Abteilung 3

Country where clinical trial is conducted

Austria, 

References & Publications (5)

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 clin — View 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. — View 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. 2023 Aug 15. doi: 10.1007/s00330-023-10017-3. Onli — View 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.e — View 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 De — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cardiac volumes	volumes of cardiac chambers in the cardiac cycle [ml], sequence- and protocol dependent	up to 1 week
Primary	cardiac performance	ejection fraction of cardiac chambers [%], sequence- and protocol dependent	up to 1 week
Primary	cardiac muscle mass	systolic and end-diastolic mass of cardiac chambers [g], sequence- and protocol dependent	up to 1 week
Primary	coronary artery anatomy	length and diameter [mm], sequence-, and protocol dependent	up to 1 week
Primary	blood flow velocity	maximum, minimum and average velocity [cm/s], sequence-, and protocol dependent	up to 1 week
Primary	blood flow vorticity	number of vortices of blood flow in the heart and surrounding great vessels, sequence and protocol dependent	up to 1 week
Primary	blood flow timing	time points of characteristic blood flow patterns in the heart and surrounding great vessels in the cardiac cycle [ms], sequence-, and protocol dependent	up to 1 week
Primary	magnetic relaxation times	systolic and diastolic T1, T2, T2* [ms], sequence- and protocol dependent	up to 1 week