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 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | Charité University Medicine Berlin |
| Funder | Charité – Universitätsmedizin Berlin |
- 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
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
Scientific
Charité Universitätsmedizin Berlin
Campus Berlin Buch – ECRC
AG Kardiale MRT - Prof. Schulz-Menger
Lindenbergweg 80
Berlin
13125
Germany
| Phone | +49 (0)30 940152903 |
|---|---|
| jeanette.schulz-menger@charite.de |
Public
Charité Universitätsmedizin Berlin
Campus Berlin Buch – ECRC
AG Kardiale MRT - Prof. Schulz-Menger
Lindenbergweg 80
Berlin
13125
Germany
| Phone | +49 (0)30 940152903 |
|---|---|
| jeanette.schulz-menger@charite.de |
Scientific
Charité Universitätsmedizin Berlin
Campus Berlin Buch – ECRC
AG Kardiale MRT - Prof. Schulz-Menger
Lindenbergweg 80
Berlin
13125
Germany
| Phone | +49 (0)30 450540611 |
|---|---|
| jan.groeschel@charite.de |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Retrospective observational cohort study |
| Secondary study design | Cohort study |
| Study type | Participant information sheet |
| Scientific title | Evaluation of Compressed Sensing techniques in MRI for the determination of cardiac function PaRameters compared to Established Segmentation Sequences (ECSPRESS) |
| Study acronym | ECSPRESS |
| Study objectives | 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(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) studied | 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 / device / biological / vaccine name(s) | |
| Primary outcome measure(s) |
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 |
| Key secondary outcome measure(s) |
1. Subjective and objective quality criteria of the cine images measured using standardized criteria after acquisition |
| Completion date | 30/06/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 200 |
| Total final enrolment | 175 |
| Key inclusion criteria | 1. Indication for cardiac magnetic resonance 2. Age >18 years |
| Key exclusion criteria | 1. Arrhythmia during the scan 2. No acquired reference cine method |
| Date of first enrolment | 01/05/2019 |
| Date of final enrolment | 29/05/2020 |
Locations
Countries of recruitment
- Germany
Study participating centre
Berlin
13125
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 14/07/2022 | 18/07/2022 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
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.
