Inter-field Strength Agreement of CMR Derived Strain

NCT04475627 | Completed

• 1 other identifier: 0735
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases

Keywords

cardiovascular magnetic resonance; left ventricular strain; field strength

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

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

  Day 1

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

  Day 1

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

  Day 1

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

  Day 1

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

  Day 1

Study Arms (2)

Participants randomised to 1.5T then 3T

Participants randomized to be scanned at 1.5T first followed by 3T

Diagnostic Test: Cardiovascular Magnetic Resonance (CMR) imaging at 1.5T; Diagnostic Test: Cardiovascular Magnetic Resonance (CMR) imaging at 3T

Participants randomised to 3T then 1.5T

Participants randomized to be scanned at 3T first followed by 1.5T

Diagnostic Test: Cardiovascular Magnetic Resonance (CMR) imaging at 1.5T; Diagnostic Test: Cardiovascular Magnetic Resonance (CMR) imaging at 3T

Interventions

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.

Participants randomised to 1.5T then 3T; Participants randomised to 3T then 1.5T

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.

Participants randomised to 1.5T then 3T; Participants randomised to 3T then 1.5T

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers, male and female, aged 18 years or above

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Leicester: lead
• University Hospitals, Leicester: collaborator

Study Sites (1)

University of Leicester

Leicester, United Kingdom

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2020
• First Posted: July 17, 2020
• Study Start: September 24, 2020
• Primary Completion: December 3, 2020
• Study Completion: December 3, 2020
• Last Updated: December 21, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)