Condition category
Not Applicable
Date applied
26/08/2019
Date assigned
22/11/2019
Last edited
22/11/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
The synchronisation of the heart cycle with image acquisition is essential in cardiovascular magnetic resonance applications. The standard method utilises the vector cardiogram (VCG) generated from different electrocardiogram (ECG) leads to trigger image acquisition. Higher magnetic field strengths lead to increased signal to noise ratio in MRI and are therefore promising for improving the diagnostic accuracy of the method, as well as for the development of new techniques. It was shown that the VCG acquired with the standard electrode placement is sufficient for field strengths up to 3T. At 7T, however, an artefact called the magnetohydrodynamic effect, severely distorts the ECG trace to the point where trigger detection is no longer feasible.
The aim of this study is to investigate the influence of different standardised electrode placements on trigger detection accuracy for different field strengths and sequences.

Who can participate?
Healthy volunteers without known cardiac disease

What does the study involve?
Participants will be scanned at clinical and ultra-high-field strengths and with different sequences for the standardised electrode placements. The impact of the electrode placement positions on trigger accuracy shall be evaluated

What are the possible benefits and risks of participating?
Cardiac MRI is considered the gold standard for the interpretation of cardiac function. Any incidental, pathological findings would be communicated with the participant.
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. This does also concern objects within the body (such as implants). This is a general limitation for the use of MRI and is therefore also applied on our study population. Any kind of implants or metal within or on the body is an exclusion criterion. If it is uncertain, if the participant had any kind of implant or metal within the body, he/she is excluded as well.

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, Berlin, Germany

When is the study starting and how long is it expected to run for?
September 2019 to June 2020

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

Who is the main contact?
Prof. 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
+49-30-450540916
stephanie.funk@charite.de

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

EKG study

Study information

Scientific title

Evaluation of the impact of standardised electrode placement positions on gating quality in ultra-high-field cardiovascular magnetic resonance

Acronym

Study hypothesis

Different electrode placement positions have an impact on the gating quality in cardiovascular magnetic resonance

Ethics approval

1. Approved 09/08/2019, ethical board of the Charité University Medicine Berlin Campus Mitte (Charitéplatz 1, 10117 Berlin, Germany; +49 30 450 517 222; ethikkommission@charite.de), ref: EA1/183/19
2. Approved 20/07/2018, ethical board of the Regional Office for Health and Social Affairs Berlin (Turmstraße 21, 10559 Berlin, Germany; +49 30 90229-1232; katja.poetzsch@lageso.berlin.de), ref: Eudamed-Number CIV-18-01-022805, DIMDI Number 00011233 (A)

Study design

Observational study

Primary study design

Observational

Secondary study design

Case series

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

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

Condition

Healthy volunteers without any known cardiac disease

Intervention

After enrolment participants will be scanned on both clinical as well as the ultra-high-field scanners.
Scan protocol involves one hour of scan time each, during which the ECG-electrodes will be placed on the standardised positions and the ECG will be recorded with the volunteer inside and outside of the scanner for each standardised position and all of the assessed sequences.
In between measurements, the volunteer will be moved outside of the scanner and the ECG-leads will be moved to the next placement position. The trigger accuracy will be evaluated by manually annotating the R-waves in the recorded ECG-trace and determining jitter, performance index and propagation delay of the actual trigger.
After the last scan, the participant will be free to leave and will not be contacted anymore. No follow-up is planned.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Gating quality assessed by calculating jitter (in ms), performance index and propagation delay (in ms) from evaluating the recorded trigger timepoints against the manually annotated recorded ECG-trace. The annotation will be performed by two independent observers.

Secondary outcome measures

Image quality assessed semiquantitatively by two observers by using a visual rating scale

Overall trial start date

01/06/2019

Overall trial end date

10/06/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. > 18 years
2. Written consent

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

16

Participant exclusion criteria

1. Any known cardiac disease
2. Contraindication to CMR

Recruitment start date

01/09/2019

Recruitment end date

01/03/2020

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
+49-30-450-540-916
stephanie.funk@charite.de

Sponsor type

University/education

Website

Funders

Funder type

University/education

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

Planned publication in a high-impact 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 data protection laws.

Intention to publish date

01/05/2021

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

03/09/2019: Trial’s existence confirmed by Charité University Medicine Berlin Campus Mitte