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
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