Analysis of heart muscle shape using cardiovascular magnetic resonance imaging
| ISRCTN | ISRCTN69274813 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN69274813 |
- Submission date
- 04/08/2019
- Registration date
- 27/11/2019
- Last edited
- 26/04/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Measuring myocardial (heart muscle) strain is of growing interest in cardiovascular magnetic resonance (CMR) imaging for the detection of subclinical myocardial dysfunction in heart disease. The aim of this study is to assess the age and gender-related reference values of myocardial strain in healthy adults and to evaluate the influence of field strength and postprocessing software.
Who can participate?
Data collected in previous studies using CMR were analysed in this study (healthy volunteers aged over 18)
What does the study involve?
CMR data is analysed to find differences in the results of the analysis using different software and different strengths of scanning devices.
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?
January 2018 to July 2019
Who is funding the study?
Charité – Universitätsmedizin Berlin (Charité University Medicine Berlin) (Germany)
Who is the main contact?
Prof. Jeanette Schulz-Menger
edyta.blaszczyk@charite.de
Contact information
Scientific
Charité University Medicine Berlin Campus Buch Working Group Kardiale MRT Lindenberger Weg 80
Berlin
13125
Germany
 ORCID ID |
0000-0003-3100-1092 |
|---|---|
| Phone | +49-30-450540615 |
| edyta.blaszczyk@charite.de |
Study information
| Study design | Retrospective proof of concept trial |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Quantification of myocardial strain assessed by Cardiovascular Magnetic Resonance feature tracking in healthy subjects – influence of post-processing |
| Study objectives | A retrospective study of strain analysis to establish standards for image acquisition and interpretation and to add further knowledge in this regard by analysing the influence of scanner field strength and analysis software package on age- and gender-related reference values of myocardial strain |
| Ethics approval(s) | Approved 04/11/2010 and 17/07/2014, ethical committee of the Charité Medical Faculty (Charité – Universitätsmedizin Berlin, Campus Charité Mitte, Charitéplatz 1, 10117 Berlin, Germany; Tel: +49 (0)30 450 517 222; Email: ethikkommission@charite.de), ref: (EA2/077/10), EA1/058/13, DOI, 0.1161/CIRCIMAGING.116.005242 |
| Health condition(s) or problem(s) studied | Myocardial strain in healthy volunteers |
| Intervention | The researchers screened healthy subjects, who were prospectively examined in former studies. The ethical committee Charite approved all of the studies. All participants were enrolled after informed consent was obtained. CMR was applied at a 1.5 and 3 T Scanner (Siemens Healthcare, Erlangen, Germany) using a 32 channel surface coil. Cine imaging is performed applying state of the art steady state precession sequences to determine the global cardiac performance in three long axis and short axis. It is a retrospective trial to evaluate the reference values of myocardial strain applying cardiovascular magnetic resonance (CMR) by analysing the influence of scanner field strength, analysis software package, age- and gender-related factors. This proof of concept trial is intended to extend the indications for CMR. Subjects were divided into three age groups: group 1 aged < 35 years, group 2 aged 35-55 years and group 3 aged > 55 years Only volunteers with similar cine protocols were included. Feature tracking analysis was performed using CVI42 software (prototype version 5.3.0, Circle Cardiovascular Imaging Inc., Calgary, Canada). All images were additionally analyzed with TomTec Image Arena (version 1.3.0.91, TomTec Imaging Systems GmbH, Unterschleissheim, Germany). Statistical analyses were performed using IBM SPSS Statistic version 23 (IBM, Armonk, US). The researchers calculated mean values and standard deviation (SD) for demographic parameters, LV function and strain measurements. Volumes were indexed to body surface area (BSA) and height. Non-parametric Mann-Whitney-U-Test for unpaired samples was used for comparisons of strain parameters between gender, analysis software and field strength. Age-related differences were analyzed using the non-parametric Kruskal-Wallis-Test. Differences were considered statistically significant at p < 0.05. |
| Intervention type | Other |
| Primary outcome measure | 1. Longitudinal strain assessed in three long-axis views: 4CV, 3CV and 2CV 2. Circumferential strain and radial strain assessed short-axis full coverage Measured using CMR at a single timepoint |
| Secondary outcome measures | There were no secondary outcome measures |
| Overall study start date | 01/01/2018 |
| Completion date | 01/07/2019 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | The researchers screened 243 healthy subjects, 67 healthy subjects were included |
| Total final enrolment | 67 |
| Key inclusion criteria | 1. Healthy male and female aged > 18 years 2. Preserved left ventricular ejection fraction in echocardiography 3. Willingness to undergo CMR 4. Willingness and ability to follow directions and complete all study procedures as specified in the protocol |
| Key exclusion criteria | 1. Any known cardiovascular risk factor 2. History of cardiac disease 3. Impaired LV ejection fraction (LVEF) (< 55%) 4. Pathologic findings in CMR 5. Incomplete CMR data for feature tracking analysis (less than three long axis and three short axis views) led to exclusion |
| Date of first enrolment | 01/01/2013 |
| Date of final enrolment | 08/11/2017 |
Locations
Countries of recruitment
- Germany
Study participating centre
Lindenberger Weg 80
Berlin
13125
Germany
Sponsor information
University/education
Working Group Kardiale MRT
Lindenberger Weg 80
Berlin
13125
Germany
| Phone | +40-30-450-540-615 |
|---|---|
| edyta.blaszczyk@charite.de | |
| Website | http://www.cmr-berlin.org |
"ROR" |
https://ror.org/001w7jn25 |
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | 30/10/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Results of this study shall be published in a high-ranking peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to reasons of data protection laws in Germany. However, upon request methodology and dataset structure can be shared. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/06/2021 | 26/04/2021 | Yes | No |
Editorial Notes
26/04/2021: Publication reference added.
10/07/2020: The intention to publish date was changed from 30/11/2019 to 30/10/2020.
18/09/2019: Trial's existence confirmed by ethics committee.
