Condition category
Circulatory System
Date applied
15/10/2020
Date assigned
20/11/2020
Last edited
20/11/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The assessment of cardiac (heart) function by cardiac magnetic resonance (CMR) is considered the most precise and reproducible method. A major drawback is the long acquisition time, so researchers want to apply new and faster scan techniques. The aim of this study is to show that compressed sensing sequences can be used to assess heart function in less time. This will facilitate the workflow and increase patient comfort while giving a clinically equivalent assessment of the heart.

Who can participate?
Patients having a CMR scan at the Helios Klinikum Berlin-Buch who are aged 18 or older and do not have an irregular heart rhythm

What does the study involve?
The study compares standard sequences and new faster sequences for the acquisition of CMR images, both obtained during a routine scan.

What are the possible benefits and risks of participating?
None

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?
April 2019 to June 2020

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

Who is the main contact?
Prof. Dr med. Jeanette Schulz-Menger
jeanette.schulz-menger@charite.de

Trial website

Contact information

Type

Scientific

Primary contact

Prof Jeanette Schulz-Menger

ORCID ID

Contact details

Charité Universitätsmedizin Berlin
Campus Berlin Buch – ECRC
AG Kardiale MRT - Prof. Schulz-Menger
Lindenbergweg 80
Berlin
13125
Germany
+49 (0)30 940152903
jeanette.schulz-menger@charite.de

Type

Public

Additional contact

Prof Jeanette Schulz-Menger

ORCID ID

Contact details

Charité Universitätsmedizin Berlin
Campus Berlin Buch – ECRC
AG Kardiale MRT - Prof. Schulz-Menger
Lindenbergweg 80
Berlin
13125
Germany
+49 (0)30 940152903
jeanette.schulz-menger@charite.de

Type

Scientific

Additional contact

Mr Jan Wolfgang Groeschel

ORCID ID

Contact details

Charité Universitätsmedizin Berlin
Campus Berlin Buch – ECRC
AG Kardiale MRT - Prof. Schulz-Menger
Lindenbergweg 80
Berlin
13125
Germany
+49 (0)30 450540611
jan.groeschel@charite.de

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

Evaluation of Compressed Sensing techniques in MRI for the determination of cardiac function PaRameters compared to Established Segmentation Sequences (ECSPRESS)

Acronym

ECSPRESS

Study hypothesis

A retrospective study of accelerated cine sequences in comparison to standard cine sequences to show that there are no relevant clinical differences in the quantitative evaluation of left and right ventricular function parameters and mass.

Ethics approval

Submission pending, ethical committee of the Charité Medical Faculty (Charité – Universitätsmedizin Berlin, Campus Charité Mitte, Charitéplatz 1, 10117 Berlin, Germany; +49 (0)30 450 517 222; ethikkommission@charite.de)

Study design

Retrospective observational cohort study

Primary study design

Observational

Secondary study design

Cohort 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 different cardiac diseases with an indication for cardiac MRI

Intervention

The researchers screened the PACS system for CMR scans obtained between May 2019 and July 2020 where new accelerated compressed sensing sequences were used. Cine images from the standard reference method steady-state precession and the compressed sensing techniques are analyzed using CVI42 software (Circle Cardiovascular Imaging Inc., Calgary, Canada) to assess the cardiac morphology. Statistical analyses are performed using IBM SPSS Statistic version 23 (IBM, Armonk, US). The researchers calculate mean values and standard deviation (SD) for demographic parameters, LV and RV function. Images are rated using subjective and objective quality criteria. Differences were considered statistically significant at p < 0.05.

Intervention type

Device

Phase

Not Applicable

Drug names

Primary outcome measure

Quantitative evaluation of left and right ventricular function parameters and mass (LVEF, LVSV, LVEDV, LVESV, LVM, RVEF, RVSV, RVEDV, RVDSV) measured by compressed sensing sequences and standard cine sequences with cardiac magnetic resonance after the scan

Secondary outcome measures

1. Subjective and objective quality criteria of the cine images measured using standardized criteria after acquisition
2. Time for each acquisition and per slice measured using the DICOM tags after the images are obtained

Overall trial start date

01/04/2019

Overall trial end date

30/06/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Indication for cardiac magnetic resonance
2. Age >18 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

200

Total final enrolment

175

Participant exclusion criteria

1. Arrhythmia during the scan
2. No acquired reference cine method

Recruitment start date

01/05/2019

Recruitment end date

29/05/2020

Locations

Countries of recruitment

Germany

Trial participating centre

Helios Klinikum Berlin-Buch
Schwanebecker Chaussee 50
Berlin
13125
Germany

Sponsor information

Organisation

Charité University Medicine Berlin

Sponsor details

Working Group Kardiale MRT
Lindenberger Weg 80
Berlin
13125
Germany
+49 (0)30 940152903
jeanette.schulz-menger@charite.de

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

For-profit companies (industry)

Location

Germany

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal. There will be no additional documents available.

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

Intention to publish date

01/06/2021

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

20/11/2020: Internal review. 15/10/2020: Trial's existence confirmed by Charite - University Medicine Berlin.