Inter-field Strength Agreement of CMR Derived Strain

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cardiovascular Diseases

Intervention / Treatment
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* Diagnostic Test: Cardiovascular Magnetic Resonance (CMR) imaging at 1.5T
* Diagnostic Test: Cardiovascular Magnetic Resonance (CMR) imaging at 3T


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants randomised to 1.5T then 3T<br>Participants randomized to be scanned at 1.5T first followed by 3T | Diagnostic Test: Cardiovascular Magnetic Resonance (CMR) imaging at 1.5T<br>* 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.<br>Diagnostic Test: Cardiovascular Magnetic Resonance (CMR) imaging at 3T<br>* 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.<br>|
| Participants randomised to 3T then 1.5T<br>Participants randomized to be scanned at 3T first followed by 1.5T | Diagnostic Test: Cardiovascular Magnetic Resonance (CMR) imaging at 1.5T<br>* 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.<br>Diagnostic Test: Cardiovascular Magnetic Resonance (CMR) imaging at 3T<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inter-field strength agreement of left ventricular global longitudinal strain (GLS) | The inter-field strength agreement of left ventricular global longitudinal strain (GLS) measured using cvi42 Tissue Tracking at 1.5T and 3T | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inter-field strength agreement of left ventricular global circumferential strain (GCS) | The inter-field strength agreement of left ventricular global circumferential strain (GCS) measured using cvi42 Tissue Tracking at 1.5T and 3T | Day 1 | 
| Inter-field strength agreement of left ventricular short- and long-axis global radial strain (GRS) | The 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 | Day 1 | 
| Inter-field strength agreement of left ventricular longitudinal peak early diastolic strain rate (long. PEDSR) | The 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 | Day 1 | 
| Inter-field strength agreement of left ventricular circumferential peak early diastolic strain rate (circum. PEDSR) | The 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 | Day 1 | 
| Inter-field strength agreement of left ventricular radial peak early diastolic strain rate (rad. PEDSR) | The 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 | Day 1 | 
| Inter-field strength agreement of left ventricular peak torsion | The inter-field strength agreement of left ventricular peak torsion measured using cvi42 Tissue Tracking at 1.5T and 3T | Day 1 | 
| Inter-vendor agreement of left ventricular systolic and diastolic strain measurements at 1.5T and 3T | The 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 | Day 1 | 
| Inter-field strength agreement of left ventricular systolic and diastolic strain measurements using cine-based imaging and tissue tagging techniques | The 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 | Day 1 | 
| Inter-field strength agreement of left and right atrial and ventricular volumes and function | The inter-field strength agreement of left and right atrial and ventricular volumes and function at 1.5T and 3T | Day 1 | 
| Inter- and intra-observer variability of left ventricular systolic and diastolic strain measurements | The inter- and intra-observer variability of left ventricular systolic and diastolic strain measurements using cvi42 Tissue Tracking at 1.5T and 3T | Day 1 | 
| Inter-field strength agreement of aortic strain | The inter-field strength agreement of aortic strain measured at 1.5T and 3T | Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiovascular magnetic resonance, left ventricular strain, field strength