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

NCT01728597 | Recruiting DMC

• 1 other identifier: CMR-12-TECH-02
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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).

Conditions

Healthy

Keywords

no history of cardiovascular diseases

Outcome Measures

Primary Outcomes (8)

• cardiac volumes

  volumes of cardiac chambers in the cardiac cycle \[ml\], sequence- and protocol dependent

  up to 1 week

• cardiac performance

  ejection fraction of cardiac chambers \[%\], sequence- and protocol dependent

  up to 1 week

• cardiac muscle mass

  systolic and end-diastolic mass of cardiac chambers \[g\], sequence- and protocol dependent

  up to 1 week

• coronary artery anatomy

  length and diameter \[mm\], sequence-, and protocol dependent

  up to 1 week

• blood flow velocity

  maximum, minimum and average velocity \[cm/s\], sequence-, and protocol dependent

  up to 1 week

• blood flow vorticity

  number of vortices of blood flow in the heart and surrounding great vessels, sequence and protocol dependent

  up to 1 week

• 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

• magnetic relaxation times

  systolic and diastolic T1, T2, T2\* \[ms\], sequence- and protocol dependent

  up to 1 week

Study Arms (1)

healthy volunteers

MR compliant volunteers with no history of cardiovascular diseases

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

healthy volunteers

You may qualify if:

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

You may not qualify if:

• pregnancy,
• claustrophobia.

Sponsors & Collaborators

• Medical University of Graz: lead
• Amt der Steiermärkischen Landesregierung, Abteilung 3: collaborator

Study Sites (1)

Medical Unitersity Graz, Department of Radiology, Division of General Radiology

Graz, Styria, 8036, Austria

RECRUITING

Related Publications (5)

• 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.

  PMID: 24475837 RESULT

• 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.

  PMID: 32557819 RESULT

• 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.

  PMID: 34023727 RESULT

• 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.

  PMID: 37580598 RESULT

• 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.

  PMID: 33975097 RESULT

Study Officials

• Ursula Reiter, PhD

  Medical Unitersity Graz, Department of Radiology, Division of General Radiology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ursula Reiter, PhD

CONTACT

+43-316-385; ursula.reiter@klinikum-graz.at

Michael Fuchsjäger, Prof. Dr.

CONTACT

+43-316-385; michael.fuchsjaeger@medunigraz.at

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: November 3, 2012
• First Posted: November 20, 2012
• Study Start: December 1, 2011
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 12, 2025

Record last verified: 2025-02

Locations

AU (1)