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Recruiting NCT01728597

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

— Observational Healthy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Healthy. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Austria
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

Primary outcome measures

  • cardiac volumes [Time frame: up to 1 week]
  • cardiac performance [Time frame: up to 1 week]
  • cardiac muscle mass [Time frame: up to 1 week]
  • coronary artery anatomy [Time frame: up to 1 week]
  • blood flow velocity [Time frame: up to 1 week]
  • blood flow vorticity [Time frame: up to 1 week]
  • blood flow timing [Time frame: up to 1 week]
  • magnetic relaxation times [Time frame: up to 1 week]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Other

Study locations

Austria · 1 center
  • Medical Unitersity Graz, Department of Radiology, Division of General Radiology — Graz

Publications

  • 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
  • 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
  • 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
  • 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
  • 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

Identifiers

NCT: NCT01728597 · CMR-12-TECH-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗