Skip to content

Inter-field Strength Agreement of CMR Derived Strain

Inter-field Strength Agreement of Myocardial Strain Measurements Using Cardiovascular Magnetic Resonance Imaging

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04475627
Enrollment
20
Registered
2020-07-17
Start date
2020-09-24
Completion date
2020-12-03
Last updated
2020-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases

Keywords

cardiovascular magnetic resonance, left ventricular strain, field strength

Brief summary

* Magnetic Resonance Imaging (MRI) scanners create a strong magnetic field around the body to produce a detailed picture of parts of the body. This can provide a lot of useful information about how the heart looks and works. * Different strengths of magnets can be used in an MRI scanner and this can affect the pictures that are produced. To scan the heart, two different magnet field strengths (1.5 tesla (T) and 3T) are mainly used. * It is currently unclear if when the heart is scanned using these different field strengths, if the measurements that tell us how well the heart squeezes and relaxes (known as 'myocardial strain') will be the same between them. * This study is investigating if myocardial strain measurements using 1.5T and 3T MRI scanners are different or if they can be used interchangeably. * Twenty healthy people without heart disease will be recruited to have two MRI scans on the same day. The order that they have their scan (either on a 1.5T MRI scanner first or a 3T MRI scanner first) will be decided randomly. * All images will then be analysed using specialist software to provide measurements of myocardial strain. These measured can then assessed to see if there is agreement between the myocardial strain results at the two MRI field strengths.

Detailed description

* This is a single-centre, randomised, cross-sectional, cross-over observational study. * Twenty healthy volunteers, aged 18 years and over will be recruited and will undergo cardiovascular magnetic resonance scans for long axis and short axis cine imaging at 1.5T and 3T. * Participation will involve one single visit where participants will be consented, randomised and then undergo scanning at both field strengths; the order of scanning at 1.5T and 3T will be randomised. There will be no follow up period. * All subjects will undergo balanced steady-state free precession (bSSFP) cine imaging at 3T and 1.5T. Tagging images will also be acquired at both field strengths. Participants will also be randomized to either have cine or tagging images obtained first on each scan. * All scans at both field strengths will be anonymised and analysed offline by a single experienced observer to determine inter-field strength agreement of left ventricular systolic and diastolic strain measurements. * Further imaging analysis will take place for secondary outcomes, including analysis using other software vendors, tagging images and aortic cine images.

Interventions

DIAGNOSTIC_TESTCardiovascular Magnetic Resonance (CMR) imaging at 1.5T

Long and short axis bSSFP cines images, long and short axis tagging images and aortic cine images will be obtained. Participants will be randomised to either have cine or tagging images obtained first.

DIAGNOSTIC_TESTCardiovascular Magnetic Resonance (CMR) imaging at 3T

Long and short axis bSSFP cines images, long and short axis tagging images and aortic cine images will be obtained. Participants will be randomised to either have cine or tagging images obtained first.

Sponsors

University Hospitals, Leicester
CollaboratorOTHER
University of Leicester
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Participant is willing and able to give informed consent for participation in the study. * Understands written and verbal English sufficiently to be able to consent and participate in study * Male or Female, aged 18 years or above. * No history of cardiovascular, respiratory, metabolic (including diabetes) or renal disease.

Exclusion criteria

* Prior cardiovascular, respiratory, metabolic (including diabetes) or renal disease. * Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study. * Any contra-indication to magnetic resonance imaging (MRI), including the presence of an implanted metal device or suspected metal foreign bodies. * Pregnant women

Design outcomes

Primary

MeasureTime frameDescription
Inter-field strength agreement of left ventricular global longitudinal strain (GLS)Day 1The inter-field strength agreement of left ventricular global longitudinal strain (GLS) measured using cvi42 Tissue Tracking at 1.5T and 3T

Secondary

MeasureTime frameDescription
Inter-field strength agreement of left ventricular global circumferential strain (GCS)Day 1The inter-field strength agreement of left ventricular global circumferential strain (GCS) measured using cvi42 Tissue Tracking at 1.5T and 3T
Inter-field strength agreement of left ventricular short- and long-axis global radial strain (GRS)Day 1The inter-field strength agreement of left ventricular short- and long-axis global radial strain (GRS) measured using cvi42 Tissue Tracking at 1.5T and 3T
Inter-field strength agreement of left ventricular circumferential peak early diastolic strain rate (circum. PEDSR)Day 1The inter-field strength agreement of left ventricular circumferential peak early diastolic strain rate (circum. PEDSR) measured using cvi42 Tissue Tracking at 1.5T and 3T
Inter-field strength agreement of left ventricular radial peak early diastolic strain rate (rad. PEDSR)Day 1The inter-field strength agreement of left ventricular radial peak early diastolic strain rate (rad. PEDSR) measured using cvi42 Tissue Tracking at 1.5T and 3T
Inter-field strength agreement of left ventricular peak torsionDay 1The inter-field strength agreement of left ventricular peak torsion measured using cvi42 Tissue Tracking at 1.5T and 3T
Inter-field strength agreement of left ventricular longitudinal peak early diastolic strain rate (long. PEDSR)Day 1The inter-field strength agreement of left ventricular longitudinal peak early diastolic strain rate (long. PEDSR) measured using cvi42 Tissue Tracking at 1.5T and 3T
Inter-field strength agreement of left ventricular systolic and diastolic strain measurements using cine-based imaging and tissue tagging techniquesDay 1The inter-field strength agreement of left ventricular systolic and diastolic strain measurements derived using cine-based imaging and tissue tagging techniques at 1.5T and 3T
Inter-field strength agreement of left and right atrial and ventricular volumes and functionDay 1The inter-field strength agreement of left and right atrial and ventricular volumes and function at 1.5T and 3T
Inter- and intra-observer variability of left ventricular systolic and diastolic strain measurementsDay 1The inter- and intra-observer variability of left ventricular systolic and diastolic strain measurements using cvi42 Tissue Tracking at 1.5T and 3T
Inter-field strength agreement of aortic strainDay 1The inter-field strength agreement of aortic strain measured at 1.5T and 3T
Inter-vendor agreement of left ventricular systolic and diastolic strain measurements at 1.5T and 3TDay 1The inter-vendor agreement of left ventricular systolic and diastolic strain measurements with different software packages (TomTec, QMass, cvi42) using cine-based imaging at 1.5T and 3T

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026