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Real-time MRI for Evaluating Cardiac Volumetry

Comparison of Standard Breath-hold Cardiac MRI With a Faster, Free-breathing Scan

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05221853
Enrollment
570
Registered
2022-02-03
Start date
2021-02-23
Completion date
2025-02-01
Last updated
2023-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Left Ventricle Abnormality

Brief summary

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.

Interventions

CMR scan at 3 Tesla

Sponsors

University of Leicester
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Patients aged ≥ 18 years 2. Referred for routine CMR imaging 3. Willing and able to give informed consent 4. Willing and able to comply with the requirements of the study 5. Able to understand written English

Exclusion criteria

1. Severe claustrophobia 2. Absolute contraindications to CMR (those with CMR conditional or safe devices will be eligible for inclusion) 3. Unable to provide informed consent 4. Participants unable to understand written English

Design outcomes

Primary

MeasureTime frameDescription
Cardiac strain assessment 21 dayLeft ventricular global circumferential strain
Cardiac volumetric assessment 41 dayRight ventricular ejection fraction
Cardiac volumetric assessment 51 dayRight ventricular end-diastolic volume
Cardiac strain assessment 11 dayLeft ventricular global longitudinal strain
Cardiac volumetric assessment 11 dayLeft ventricular ejection fraction
Cardiac volumetric assessment 21 dayLeft ventricular end-diastolic volume
Cardiac volumetric assessment 31 dayLeft ventricular myocardial mass

Secondary

MeasureTime frameDescription
Image quality assessment1 dayImage quality of each scan component, assessed visually on a 4-point score - excellent (3), good (2), moderate (1) and poor (0).
Body-surface area1 dayplanimetered body-surface area
Time1 daythe time required for each scan under evaluation (real-time Cine and standard Cine)

Countries

United Kingdom

Contacts

Primary ContactJayanth Arnold, BMBCh
jra14@le.ac.uk01162583038
Backup ContactMohamed Elshibly
mmme1@le.ac.uk01162583038

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026