- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01728597
Non-contrast Enhanced Cardiac Magnetic Resonance Normal Values and Imaging Protocols (CMR-TECH)
Optimization of Non-contrast Enhanced 1.5 Tesla and 3 Tesla Cardiac Magnetic Resonance Imaging Techniques and Acquisition of Normal Values
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).
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Ursula Reiter, PhD
- Phone Number: 83347 +43-316-385
- Email: ursula.reiter@klinikum-graz.at
Study Contact Backup
- Name: Michael Fuchsjäger, Prof. Dr.
- Phone Number: 2411 +43-316-385
- Email: michael.fuchsjaeger@medunigraz.at
Study Locations
-
-
Styria
-
Graz, Styria, Austria, 8036
- Recruiting
- Medical Unitersity Graz, Department of Radiology, Division of General Radiology
-
Contact:
- Ursula Reiter, PhD
- Phone Number: 83347 +43-316-385
- Email: ursula.reiter@klinikum-graz.at
-
Contact:
- Michael Fuchsjäger, Prof. Dr.
- Phone Number: 2411 +43-316-385
- Email: michael.fuchsjaeger@medunigraz.at
-
Principal Investigator:
- Ursula Reiter, PD DI Dr.
-
Sub-Investigator:
- Gert Reiter, PD DI Dr.
-
Sub-Investigator:
- Clemens Reiter, Dr.
-
Sub-Investigator:
- Corina Kräuter, DI
-
Sub-Investigator:
- Michael Fuchsjäger, Prof. Dr.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
healthy volunteers
MR compliant volunteers with no history of cardiovascular diseases
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
cardiac volumes
Time Frame: up to 1 week
|
volumes of cardiac chambers in the cardiac cycle [ml], sequence- and protocol dependent
|
up to 1 week
|
cardiac performance
Time Frame: up to 1 week
|
ejection fraction of cardiac chambers [%], sequence- and protocol dependent
|
up to 1 week
|
cardiac muscle mass
Time Frame: up to 1 week
|
systolic and end-diastolic mass of cardiac chambers [g], sequence- and protocol dependent
|
up to 1 week
|
coronary artery anatomy
Time Frame: up to 1 week
|
length and diameter [mm], sequence-, and protocol dependent
|
up to 1 week
|
blood flow velocity
Time Frame: up to 1 week
|
maximum, minimum and average velocity [cm/s], sequence-, and protocol dependent
|
up to 1 week
|
blood flow vorticity
Time Frame: up to 1 week
|
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 Frame: up to 1 week
|
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
Time Frame: up to 1 week
|
systolic and diastolic T1, T2, T2* [ms], sequence- and protocol dependent
|
up to 1 week
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ursula Reiter, PhD, Medical Unitersity Graz, Department of Radiology, Division of General Radiology
Publications and helpful links
General 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.
- 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.
- 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.
- 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. Online ahead of print.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CMR-12-TECH-02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
Hasselt UniversityRecruitingHealthy | Healthy AgingBelgium
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
University of PennsylvaniaActive, not recruitingHealthy | Healthy AgingUnited States
-
Chalmers University of TechnologyGöteborg UniversityCompletedHealthy | Nutrition, HealthySweden
-
University of ManitobaNot yet recruitingHealthy | Healthy Diet