Comparison of new accelerated sequences and standard sequences in cardiac magnetic resonance for the evaluation of cardiac function parameters and mass

ISRCTN ISRCTN12344380
DOI https://doi.org/10.1186/ISRCTN12344380
Submission date
15/10/2020
Registration date
20/11/2020
Last edited
18/07/2022
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Prof Jeanette Schulz-Menger
Scientific

Charité Universitätsmedizin Berlin
Campus Berlin Buch – ECRC
AG Kardiale MRT - Prof. Schulz-Menger
Lindenbergweg 80
Berlin
13125
Germany

Phone +49 (0)30 940152903
Email jeanette.schulz-menger@charite.de
Prof Jeanette Schulz-Menger
Public

Charité Universitätsmedizin Berlin
Campus Berlin Buch – ECRC
AG Kardiale MRT - Prof. Schulz-Menger
Lindenbergweg 80
Berlin
13125
Germany

Phone +49 (0)30 940152903
Email jeanette.schulz-menger@charite.de
Mr Jan Wolfgang Groeschel
Scientific

Charité Universitätsmedizin Berlin
Campus Berlin Buch – ECRC
AG Kardiale MRT - Prof. Schulz-Menger
Lindenbergweg 80
Berlin
13125
Germany

Phone +49 (0)30 450540611
Email jan.groeschel@charite.de

Study information

Study designRetrospective observational cohort study
Primary study designObservational
Secondary study designCohort study
Study setting(s)Hospital
Study typeDiagnostic
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleEvaluation of Compressed Sensing techniques in MRI for the determination of cardiac function PaRameters compared to Established Segmentation Sequences (ECSPRESS)
Study acronymECSPRESS
Study objectivesA 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(s)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)
Health condition(s) or problem(s) studiedPatients with different cardiac diseases with an indication for cardiac MRI
InterventionThe 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 typeDevice
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)
Primary outcome measureQuantitative 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 measures1. 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 study start date01/04/2019
Completion date30/06/2020

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants200
Total final enrolment175
Key inclusion criteria1. Indication for cardiac magnetic resonance
2. Age >18 years
Key exclusion criteria1. Arrhythmia during the scan
2. No acquired reference cine method
Date of first enrolment01/05/2019
Date of final enrolment29/05/2020

Locations

Countries of recruitment

  • Germany

Study participating centre

Helios Klinikum Berlin-Buch
Schwanebecker Chaussee 50
Berlin
13125
Germany

Sponsor information

Charité University Medicine Berlin
University/education

Working Group Kardiale MRT
Lindenberger Weg 80
Berlin
13125
Germany

Phone +49 (0)30 940152903
Email jeanette.schulz-menger@charite.de
Website http://www.cmr-berlin.org

Funders

Funder type

University/education

Charité – Universitätsmedizin Berlin
Private sector organisation / For-profit companies (industry)
Alternative name(s)
Medical School - Charité - University Medicine Berlin
Location
Germany

Results and Publications

Intention to publish date01/06/2021
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot expected to be made available
Publication and dissemination planPlanned publication in a high-impact peer-reviewed journal. There will be no additional documents available.
IPD sharing planThe 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.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 14/07/2022 18/07/2022 Yes No

Editorial Notes

18/07/2022: Publication reference added.
20/11/2020: Internal review.
15/10/2020: Trial's existence confirmed by Charite - University Medicine Berlin.