Clinical trial NCT04475627: Inter-field Strength Agreement of CMR Derived Strain
Official title: Inter-field Strength Agreement of Myocardial Strain Measurements Using Cardiovascular Magnetic Resonance Imaging
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Keywords: cardiovascular magnetic resonance
left ventricular strain
field strength
Lead sponsor: University of Leicester
Sponsor class: OTHER
Collaborators: name: University Hospitals, Leicester
First posted: 2020-07-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers, male and female, aged 18 years or above

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.

Eligibility criteria: 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

Primary outcomes:
measure: Inter-field strength agreement of left ventricular global longitudinal strain (GLS)
timeFrame: Day 1
Secondary outcomes:
measure: Inter-field strength agreement of left ventricular global circumferential strain (GCS)
timeFrame: Day 1
measure: Inter-field strength agreement of left ventricular short- and long-axis global radial strain (GRS)
timeFrame: Day 1
measure: Inter-field strength agreement of left ventricular longitudinal peak early diastolic strain rate (long. PEDSR)
timeFrame: Day 1
measure: Inter-field strength agreement of left ventricular circumferential peak early diastolic strain rate (circum. PEDSR)
timeFrame: Day 1
measure: Inter-field strength agreement of left ventricular radial peak early diastolic strain rate (rad. PEDSR)
timeFrame: Day 1
measure: Inter-field strength agreement of left ventricular peak torsion
timeFrame: Day 1
measure: Inter-vendor agreement of left ventricular systolic and diastolic strain measurements at 1.5T and 3T
timeFrame: Day 1
measure: Inter-field strength agreement of left ventricular systolic and diastolic strain measurements using cine-based imaging and tissue tagging techniques
timeFrame: Day 1
measure: Inter-field strength agreement of left and right atrial and ventricular volumes and function
timeFrame: Day 1
measure: Inter- and intra-observer variability of left ventricular systolic and diastolic strain measurements
timeFrame: Day 1
measure: Inter-field strength agreement of aortic strain
timeFrame: Day 1
Other outcomes:
Locations:
city: Leicester
country: United Kingdom
facility: University of Leicester
Study officials:
References: