Condition category
Circulatory System
Date applied
04/07/2018
Date assigned
07/08/2018
Last edited
07/08/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
4D flow is a newly developed MRI scanner that allows blood flow to be visualized and quantified. This means that blood flow pattern, volumes, velocity (aortic hemodynamics) can be examined, along with wall shear stress, which shows whether the aorta is affected by cardiac disease.
Aortic stenosis, where the opening of the aortic valve is constricted, and bicuspid valves, are
both forms of aortic valve disease. This can lead to altered blood flow patterns and increased
wall shear stress. This study aims to investigate the changes in aortic blood flow and wall shear
stress over time in patients with aortic valve diseases.

Who can participate?
Patients over 18 years of age with either a tricuspid aortic valve with stenosis or a bicuspid
aortic valve.

What does the study involve?
Each patient receives two cardiovascular MRI examinations. The first is after inclusion in the
study and the second is 4-7 years later.

What are the possible benefits and risks of participating?
A benefit to patients is a thorough, high-level examination of the heart. Clinically relevant information on the disease can be made available to the participant upon request and the participant will be made aware of any incidental pathological findings.
The possible risk to patients is the use of a magnetic field to collect the images, which means
that any metallic (magnetic) objects, along with objects within the body (such as implants) are
of risk. Additionally, there is a small risk of temporary dizziness and light flashes whilst leaving
the MRI scanner.

Where is the study run from?
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
Lindenberger Weg 80
Berlin
Germany
13125

When is the study starting and how long is it expected to run for?
The study started in November 2009 and will run until May 2018.

Who is funding the study?
Working Group Kardiale MRT of the Charité University Medicine Berlin.

Who is the main contact?
Professor Jeanette Schulz-Menger
stephanie.funk@charite.de

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 FU (internal study code)

Study information

Scientific title

Longitudinal evaluation of aortic hemodynamics in patients with aortic stenosis and patients with bicuspid aortic valve using 4D flow in cardiovascular magnetic resonance imaging - A follow up investigation

Acronym

Study hypothesis

4D flow MRI can show changes of aortic flow patterns and additional hemodynamic parameters such as wall shear stress in patients with aortic valve pathologies over time. The pattern of aortic blood flow turbulences, and extent and degree of the wall shear stress can predict development or progress of changes in the ascending aorta.

Ethics approval

Charité University of Berlin, 27/07/2011, EA1/183/11

Study design

Observational longitudinal single-center study over the time of up to 7 years

Primary study design

Observational

Secondary study design

Longitudinal study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

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

Condition

Patients with tricuspid aortic valve or bicuspid aortic valve, with or without stenosis.

Intervention

Two cardiac magnetic resonance examinations were performed per patient to acquire images displaying the aortic flow. Each patient received one examination after inclusion in the study and one 4 to 7 years later. The examination took approximately 1 hour and was performed using 3 Tesla Siemens Verio Scanner and was without application of contrast agent or any other drug. A physician specialising in cardiac MRI was present during the whole time of the examination.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measure

Images of the aorta and aortic flow were acquired using 4D flow MRI at the beginning of the study and 4-7 years following this. These images were analysed for the following and the results from each time point compared:
1. Flow patterns
2. Volumes
3. Wall shear stress

Secondary outcome measures

N/A

Overall trial start date

12/11/2009

Overall trial end date

31/05/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Over 18 years of age
2. Written consent
3. Known aortic stenosis and/or bicuspid aortic valve

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

70

Participant exclusion criteria

1. Claustrophobia
2. Contraindications to CMR, including implants or metallic objects
3. Pregnant

Recruitment start date

27/07/2011

Recruitment end date

01/05/2018

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
Germany

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

Not defined

Funder name

Charité University Medicine Berlin - Working Group Kardiale MRT

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Published in a high-ranking peer-reviewed journal

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

Intention to publish date

31/05/2019

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes