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Completed

NCT Number: NCT04475627

Inter-field Strength Agreement of CMR Derived Strain

* 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.

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Key information

Conditions

Cardiovascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Leicester

Leicester, United Kingdom

About this study

  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cardiovascular Magnetic Resonance (CMR) imaging at 1.5T

Diagnostic Test

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.

Cardiovascular Magnetic Resonance (CMR) imaging at 3T

Diagnostic Test

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.

Primary outcomes

  1. Inter-field strength agreement of left ventricular global longitudinal strain (GLS)

    Time frame: Day 1

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

Secondary outcomes

  1. Inter-field strength agreement of left ventricular global circumferential strain (GCS)

    Time frame: Day 1

    The inter-field strength agreement of left ventricular global circumferential strain (GCS) measured using cvi42 Tissue Tracking at 1.5T and 3T

  2. Inter-field strength agreement of left ventricular short- and long-axis global radial strain (GRS)

    Time frame: Day 1

    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

  3. Inter-field strength agreement of left ventricular longitudinal peak early diastolic strain rate (long. PEDSR)

    Time frame: Day 1

    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

  4. Inter-field strength agreement of left ventricular circumferential peak early diastolic strain rate (circum. PEDSR)

    Time frame: Day 1

    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

  5. Inter-field strength agreement of left ventricular radial peak early diastolic strain rate (rad. PEDSR)

    Time frame: Day 1

    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

  6. Inter-field strength agreement of left ventricular peak torsion

    Time frame: Day 1

    The inter-field strength agreement of left ventricular peak torsion measured using cvi42 Tissue Tracking at 1.5T and 3T

  7. Inter-vendor agreement of left ventricular systolic and diastolic strain measurements at 1.5T and 3T

    Time frame: Day 1

    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

  8. Inter-field strength agreement of left ventricular systolic and diastolic strain measurements using cine-based imaging and tissue tagging techniques

    Time frame: Day 1

    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

  9. Inter-field strength agreement of left and right atrial and ventricular volumes and function

    Time frame: Day 1

    The inter-field strength agreement of left and right atrial and ventricular volumes and function at 1.5T and 3T

  10. Inter- and intra-observer variability of left ventricular systolic and diastolic strain measurements

    Time frame: Day 1

    The inter- and intra-observer variability of left ventricular systolic and diastolic strain measurements using cvi42 Tissue Tracking at 1.5T and 3T

  11. Inter-field strength agreement of aortic strain

    Time frame: Day 1

    The inter-field strength agreement of aortic strain measured at 1.5T and 3T

Sponsors and collaborators

Lead sponsor

University of Leicester

Other

Collaborators

  • University Hospitals, Leicester

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jul 17, 2020
Registry last updated
Dec 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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