Condition category
Not Applicable
Date applied
08/02/2018
Date assigned
15/03/2018
Last edited
15/03/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Two-dimensional flow imaging in cardiac (heart) MRI is a standard technique and well established. However, it only measures blood flow volumes in one cross-sectional plane of the aorta, so it cannot give information about wall shear stress or maximum velocity. A newly developed sequence for cardiovascular MRI can be used to measure blood flow and its impact on surrounding tissue in three dimensions and over time (i.e. over one cardiac cycle) - the common name for the sequence is therefore 4D-Flow. Blood flow pattern, volume and velocity can all be measured. The wall-shear stress of the aorta (the largest artery) can be examined, showing where the aorta is affected and altered by cardiac pathology (heart disease). Different types of this sequence have been developed, and it can be used at MRI scanners of different field strengths. It is important to know whether there are differences in the results when using different sequences or MRI scanners. The aim of this study is to compare three different sequences and three different field strengths in healthy volunteers, and to compare all 4D-Flow exams to the reference of two-dimensional flow measurement.

Who can participate?
Healthy volunteers, aged over 18

What does the study involve?
Three different sequences and three different field strengths are compared in healthy volunteers. All 4D Flow scans are assessed to measure blood flow in the thoracic aorta, wall shear stress and peak velocity, and are compared with two-dimensional flow measurement.

What are the possible benefits and risks of participating?
Cardiac MRI is considered the gold standard for measuring heart function. Participants may benefit from a thorough, high-level examination of the heart. Results can - upon request - be made available to the participant. Any incidental pathological findings are communicated with the participant as well. Future patients may benefit from a useful diagnostic tool in clinical routine. 4D Flow has been proven to provide additional information in certain pathologies and can help with guiding treatment. Standardization of the technique is crucial for its use in clinical routine. The risk of an MRI exam are generally small (seldom temporary dizziness and light flashes, ending with leaving the MRI scanner). The biggest risk centers around the fact that a magnetic field is induced to gather the images. Therefore, metallic (magnetic) objects are of risk, including objects within the body such as implants. This is a general limitation for the use of MRI and is therefore also applied in this study. People with any kind of implant or metal within or on the body cannot participate.

Where is the study run from?
Charité University Medicine Berlin (Germany)

When is the study starting and how long is it expected to run for?
June 2016 to March 2018

Who is funding the study?
Charité University Medicine Berlin (Germany)

Who is the main contact?
Prof. Jeanette Schulz-Menger

Trial website

Contact information

Type

Scientific

Primary contact

Prof Jeanette Schulz-Menger

ORCID ID

http://orcid.org/0000-0003-3100-1092

Contact details

Charité University Medicine Berlin Campus Buch
Working Group Kardiale MRT Lindenberger Weg 80
Berlin
1325
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

4D Comparison (internal study code)

Study information

Scientific title

Impact of field strength (1.5, 3.0 and 7.0 Tesla) and sequence on quantification of aortic flow volumes, peak velocity and wall shear stress using 4D flow MRI

Acronym

Study hypothesis

Application of different techniques for measurement of haemodynamics in the Aorta ascendens does not have a significant influence on quantitative parameters.

Ethics approval

The ethics board of the Charité University Medicine Berlin Campus Mitte:
1. 1.5 Tesla and 3.0 Tesla: 09/11/2012, ref: EA 1/258/12
2. First amendment: 30/05/2014
3. 7.0 Tesla: 25/08/2009, ref: EA 1/054/09

Study design

Observational feasibility study

Primary study design

Observational

Secondary study design

Feasibility study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Healthy volunteers without any known cardiac disease

Intervention

This is an observational study comparing three different techniques of visualization of blood flow in the aorta ascendens at three different cardiac MRI scanners with different field strengths (1.5 Tesla, 3.0 Tesla, 7.0 Tesla) in healthy volunteers. It serves at the same time as a feasibility study of this particular technique at 7.0 Tesla cardiac MRI.

Three different sequences and three different field strengths (1.5 Tesla, 3.0 Tesla and 7.0 Tesla) are compared in 10 healthy volunteers. All 4D-Flow exams are also compared to the reference of two-dimensional flow measurement. All 4D Flow scans are assessed as follows: blood flow in the thoracic aorta is visualized, forward-, backward- and net- flow is quantified. Wall shear stress and peak velocity are visualized and quantified. In the reference two-dimensional flow measurement forward-, backward- and net-flow is quantified.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Blood flow volume in the thoracic aorta in each tested MR sequence over one cardiac cycle measured by three-dimensional cardiac magnetic resonance

Secondary outcome measures

Velocity of the blood flow and wall shear stress in the ascending aorta in each tested MR sequence over one cardiac cycle measured by three-dimensional cardiac magnetic resonance

Overall trial start date

01/06/2016

Overall trial end date

31/03/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Age > 18 years
2. Written consent

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

10

Participant exclusion criteria

1. Any known cardiac disease
2. Contraindication to CMR

Recruitment start date

01/11/2016

Recruitment end date

31/05/2017

Locations

Countries of recruitment

Germany

Trial participating centre

Working Group on Cardiovascular Magnetic Resonance, Experimental and Clinical Research Center a joint cooperation between the Charité University Medicine Berlin and the Max-Delbrueck Center for Molecular Medicine, and HELIOS Klinikum Berlin Buch, Department of Cardiology and Nephrology, Berlin, Germany
Lindenberger Weg 80
Berlin
13125

Sponsor information

Organisation

Charité University Medicine Berlin

Sponsor details

Working Group Kardiale MRT Lindenberger Weg 80
Berlin
13125
Germany

Sponsor type

University/education

Website

http://www.cmr-berlin.org

Funders

Funder type

University/education

Funder name

Charité – Universitätsmedizin Berlin

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

Germany

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal, probably within the next year.

IPD sharing statement
The datasets generated during and/or analysed during the current study are not expected to be made available due to data protection laws in Germany. However, upon request methodology and dataset structure can be shared.

Intention to publish date

12/02/2019

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes