Left Ventricle AbnormalityNCT05221853
Real-time MRI for Evaluating Cardiac Volumetry
An observational study of Left Ventricle Abnormality, run by University of Leicester at 1 site in United Kingdom.
Trial summary
This study will compare the accuracy of a real-time Cine sequence in assessing cardiac volumetry. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Left Ventricle Abnormality
- What is being tested?
- cardiovascular magnetic resonance
- How many people
- 570 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Feb 2021to 1 Feb 2025
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Adults patients referred for routine cardiac MRI at Glenfield Hospital.
Who may be able to join
- Patients aged ≥ 18 years
- Referred for routine CMR imaging
- Willing and able to give informed consent
- Willing and able to comply with the requirements of the study
- Able to understand written English
Who cannot join
- Severe claustrophobia
- Absolute contraindications to CMR (those with CMR conditional or safe devices will be eligible for inclusion)
- Unable to provide informed consent
- Participants unable to understand written English
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Glenfield Hospital
Leicester, Leics, LE3 9QP
Jayanth Arnold, 01162583038, jra14@le.ac.uk
About this study
Official title: Comparison of Standard Breath-hold Cardiac MRI With a Faster, Free-breathing Scan
This study will compare the accuracy of a real-time Cine sequence in assessing cardiac volumetry.
Read the detailed description
This is a single-centre prospective study involving up to 570 patients with known or suspected cardiac disease referred for routine clinical cardiovascular magnetic resonance (CMR) assessment at Glenfield General Hospital, Leicester. In addition to standard multi-breath-hold steady-state free precession (SSFP) imaging (undertaken as part of the routine scan), each patient will also undergo additional imaging with a non-breath-hold multi-slice real-time cine sequence.
The primary outcome is the assessment of cardiac volumetry and function (end-diastolic volume, end-systolic volume, stroke volume, ejection fraction and myocardial mass) as measured by (1) the standard multi-breath-hold SSFP technique and (2) the non-breath-hold multi-slice real-time cine sequence. Secondary outcome measures will be (1) the time required for each scan, and (2) image quality for each scan. An additional secondary outcome will be to compare indexed cardiac volumes with those indexed according to measured body-surface area.
- Conditions
- Left Ventricle Abnormality
- Being tested
- cardiovascular magnetic resonance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiovascular magnetic resonanceDiagnostic test
CMR scan at 3 Tesla
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac volumetric assessment 1
Left ventricular ejection fraction
Measured: 1 day
Cardiac volumetric assessment 2
Left ventricular end-diastolic volume
Measured: 1 day
Cardiac volumetric assessment 3
Left ventricular myocardial mass
Measured: 1 day
Cardiac volumetric assessment 4
Right ventricular ejection fraction
Measured: 1 day
Cardiac volumetric assessment 5
Right ventricular end-diastolic volume
Measured: 1 day
Cardiac strain assessment 1
Left ventricular global longitudinal strain
Measured: 1 day
Cardiac strain assessment 2
Left ventricular global circumferential strain
Measured: 1 day
Secondary outcomes (3)
Time
the time required for each scan under evaluation (real-time Cine and standard Cine)
Measured: 1 day
Image quality assessment
Image quality of each scan component, assessed visually on a 4-point score - excellent (3), good (2), moderate (1) and poor (0).
Measured: 1 day
Body-surface area
planimetered body-surface area
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2022
- Study start23 Feb 2021
- Primary completion1 Feb 2025 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Left Ventricle AbnormalityStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 570 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leicester
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jayanth Arnold, Principal investigator, University of Leicester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05221853
- Sponsor's protocol ID
- 0768
- Other IDs
- 270285
- Status last verified
- Nov 2023
- First submitted
- 15 Nov 2021
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no plan to share data
Publications
Elshibly M, Shergill S, Parke K, Budgeon C, England R, Grafton-Clarke C, Elshibly F, Kellman P, McCann GP, Arnold JR. Standard breath-hold versus free-breathing real-time cine cardiac MRI-a prospective randomized comparison in patients with known or suspected cardiac disease. Eur Heart J Imaging Methods Pract. 2025 Apr 25;3(1):qyaf042. doi: 10.1093/ehjimp/qyaf042. eCollection 2025 Jan.
PubMed 40308862
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Standard Breath-hold Cardiac MRI With a Faster, Free-breathing Scan
- ClinicalTrials.gov ID
- NCT05221853
- Acronym / sponsor ID
- 0768
- Conditions
- Left Ventricle Abnormality
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 570 participants (estimated)
- Lead sponsor
- University of LeicesterUniversity, hospital or other
- Study start
- 23 Feb 2021 (actual)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 3 Feb 2022 (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.
This study will compare the accuracy of a real-time Cine sequence in assessing cardiac volumetry.
Detailed description
This is a single-centre prospective study involving up to 570 patients with known or suspected cardiac disease referred for routine clinical cardiovascular magnetic resonance (CMR) assessment at Glenfield General Hospital, Leicester. In addition to standard multi-breath-hold steady-state free precession (SSFP) imaging (undertaken as part of the routine scan), each patient will also undergo additional imaging with a non-breath-hold multi-slice real-time cine sequence.
The primary outcome is the assessment of cardiac volumetry and function (end-diastolic volume, end-systolic volume, stroke volume, ejection fraction and myocardial mass) as measured by (1) the standard multi-breath-hold SSFP technique and (2) the non-breath-hold multi-slice real-time cine sequence. Secondary outcome measures will be (1) the time required for each scan, and (2) image quality for each scan. An additional secondary outcome will be to compare indexed cardiac volumes with those indexed according to measured body-surface area.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults patients referred for routine cardiac MRI at Glenfield Hospital.
Key inclusion criteria (5 listed)
- Patients aged ≥ 18 years
- Referred for routine CMR imaging
- Willing and able to give informed consent
- Willing and able to comply with the requirements of the study
- Able to understand written English
Key exclusion criteria (4 listed)
- Severe claustrophobia
- Absolute contraindications to CMR (those with CMR conditional or safe devices will be eligible for inclusion)
- Unable to provide informed consent
- Participants unable to understand written English
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 resonanceCMR scan at 3 Tesla | Diagnostic test | – |
Primary outcome
Cardiac volumetric assessment 1
Time frame: 1 day
Left ventricular ejection fraction
Cardiac volumetric assessment 2
Time frame: 1 day
Left ventricular end-diastolic volume
Cardiac volumetric assessment 3
Time frame: 1 day
Left ventricular myocardial mass
Cardiac volumetric assessment 4
Time frame: 1 day
Right ventricular ejection fraction
Cardiac volumetric assessment 5
Time frame: 1 day
Right ventricular end-diastolic volume
Cardiac strain assessment 1
Time frame: 1 day
Left ventricular global longitudinal strain
Cardiac strain assessment 2
Time frame: 1 day
Left ventricular global circumferential strain
3 secondary outcomes
Time
Time frame: 1 day
Image quality assessment
Time frame: 1 day
Body-surface area
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Derived from this study: PubMed 40308862Elshibly M, Shergill S, Parke K, Budgeon C, England R, Grafton-Clarke C, Elshibly F, Kellman P, McCann GP, Arnold JR. Standard breath-hold versus free-breathing real-time cine cardiac MRI-a prospective randomized comparison in patients with known or suspected cardiac disease. Eur Heart J Imaging Methods Pract. 2025 Apr 25;3(1):qyaf042. doi: 10.1093/ehjimp/qyaf042. eCollection 2025 Jan.
- Individual participant dataSharing planned: No. no plan to share data
Related trials for Left Ventricle Abnormality
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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.
Jayanth Arnold principal investigator
University of Leicester
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 Left Ventricle Abnormality, 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 5 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: status not confirmed, as of the sponsor's last update on 29 Nov 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jayanth Arnold, BMBCh (01162583038, jra14@le.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac volumetric assessment 1 (time frame: 1 day). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05221853, which also lists 1 linked publication.
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 29 Nov 2023.