Cardiovascular DiseasesNCT04475627
Inter-field Strength Agreement of CMR Derived Strain
An observational study of Cardiovascular Diseases, run by University of Leicester at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Cardiovascular Magnetic Resonance (CMR) imaging at 1.5T and Cardiovascular Magnetic Resonance (CMR) imaging at 3T
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Sep 2020to 3 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteers, male and female, aged 18 years or above
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Inter-field Strength Agreement of Myocardial Strain Measurements Using Cardiovascular Magnetic Resonance Imaging
- 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.
Read the 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.
- Conditions
- Cardiovascular Diseases
- Being tested
- Cardiovascular Magnetic Resonance (CMR) imaging at 1.5T, Cardiovascular Magnetic Resonance (CMR) imaging at 3T
- Keywords
- cardiovascular magnetic resonance, left ventricular strain, field strength
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiovascular Magnetic Resonance (CMR) imaging at 1.5TDiagnostic 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 3TDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Participants randomised to 1.5T then 3T | Participants randomized to be scanned at 1.5T first followed by 3T Receives: 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 Receives: Diagnostic Test: Cardiovascular Magnetic Resonance (CMR) imaging at 1.5T; Diagnostic Test: Cardiovascular Magnetic Resonance (CMR) imaging at 3T |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 1
Secondary outcomes (11)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Day 1
Inter-field strength agreement of aortic strain
The inter-field strength agreement of aortic strain measured at 1.5T and 3T
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2020
- Study start24 Sep 2020
- Primary completion3 Dec 2020
- Study completion3 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leicester
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospitals, Leicester
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04475627
- Sponsor's protocol ID
- 0735
- Status last verified
- Dec 2020
- First submitted
- 2 Jul 2020
- Last updated
- 21 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inter-field Strength Agreement of Myocardial Strain Measurements Using Cardiovascular Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT04475627
- Acronym / sponsor ID
- 0735
- Conditions
- Cardiovascular Diseases
- Keywords
- cardiovascular magnetic resonance, left ventricular strain, field strength
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of LeicesterUniversity, hospital or other
- Collaborators
- University Hospitals, Leicester
- Study start
- 24 Sep 2020 (actual)
- Primary completion
- 3 Dec 2020 (actual)
- Study completion
- 3 Dec 2020 (actual)
- First posted
- 17 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants randomised to 1.5T then 3T | – | Diagnostic Test: Cardiovascular Magnetic Resonance (CMR) imaging at 1.5T, Diagnostic Test: Cardiovascular Magnetic Resonance (CMR) imaging at 3TParticipants randomized to be scanned at 1.5T first followed by 3T |
| Participants randomised to 3T then 1.5T | – | Diagnostic Test: Cardiovascular Magnetic Resonance (CMR) imaging at 1.5T, Diagnostic Test: Cardiovascular Magnetic Resonance (CMR) imaging at 3TParticipants randomized to be scanned at 3T first followed by 1.5T |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers, male and female, aged 18 years or above
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiovascular Magnetic Resonance (CMR) imaging at 1.5TLong 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 test | Participants randomised to 1.5T then 3T, Participants randomised to 3T then 1.5T |
| Cardiovascular Magnetic Resonance (CMR) imaging at 3TLong 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 test | Participants randomised to 1.5T then 3T, Participants randomised to 3T then 1.5T |
Primary outcome
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
11 secondary outcomes
Inter-field strength agreement of left ventricular global circumferential strain (GCS)
Time frame: Day 1
Inter-field strength agreement of left ventricular short- and long-axis global radial strain (GRS)
Time frame: Day 1
Inter-field strength agreement of left ventricular longitudinal peak early diastolic strain rate (long. PEDSR)
Time frame: Day 1
Inter-field strength agreement of left ventricular circumferential peak early diastolic strain rate (circum. PEDSR)
Time frame: Day 1
Inter-field strength agreement of left ventricular radial peak early diastolic strain rate (rad. PEDSR)
Time frame: Day 1
Inter-field strength agreement of left ventricular peak torsion
Time frame: Day 1
Inter-vendor agreement of left ventricular systolic and diastolic strain measurements at 1.5T and 3T
Time frame: Day 1
Inter-field strength agreement of left ventricular systolic and diastolic strain measurements using cine-based imaging and tissue tagging techniques
Time frame: Day 1
Inter-field strength agreement of left and right atrial and ventricular volumes and function
Time frame: Day 1
Inter- and intra-observer variability of left ventricular systolic and diastolic strain measurements
Time frame: Day 1
Inter-field strength agreement of aortic strain
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases, run by University of Leicester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inter-field strength agreement of left ventricular global longitudinal strain (GLS) (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2020.