Plain English Summary
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
Trial website
Contact information
Type
Scientific
Primary contact
Prof Jeanette Schulz-Menger
ORCID ID
http://orcid.org/0000-0003-3100-1092
Contact details
Charité University Medicine Berlin Campus Buch Working Group Kardiale MRT Lindenberger Weg 80
Berlin
13125
Germany
+49-30-450540615
edyta.blaszczyk@charite.de
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
Nil known
Study information
Scientific title
Quantification of myocardial strain assessed by Cardiovascular Magnetic Resonance feature tracking in healthy subjects – influence of post-processing
Acronym
Study hypothesis
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
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
Study design
Retrospective proof of concept trial
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 the contact details to request a patient information sheet
Condition
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
Phase
Drug names
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 trial start date
01/01/2018
Overall trial end date
01/07/2019
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Healthy volunteer
Age group
Adult
Gender
Both
Target number of participants
The researchers screened 243 healthy subjects, 67 healthy subjects were included
Total final enrolment
67
Participant 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
Recruitment start date
01/01/2013
Recruitment end date
08/11/2017
Locations
Countries of recruitment
Germany
Trial participating centre
Charité University Medicine Berlin
Working Group Kardiale MRT
Lindenberger Weg 80
Berlin
13125
Germany
Sponsor information
Organisation
Charité University Medicine Berlin
Sponsor details
Working Group Kardiale MRT
Lindenberger Weg 80
Berlin
13125
Germany
+40-30-450-540-615
edyta.blaszczyk@charite.de
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Charité – Universitätsmedizin Berlin
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Results of this study shall be published in a high-ranking peer-reviewed journal.
IPD sharing statement
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.
Intention to publish date
30/10/2020
Participant level data
Not expected to be available
Basic results (scientific)
Publication list