Real-time MRI for Evaluating Cardiac Volumetry

Recruiting

• Conditions: Left Ventricle Abnormality

• Registration Number: NCT05221853
• Lead Sponsor: University of Leicester

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.

Study Timeline

• Study Start: 2021-02-23
• Study First Submitted: 2021-11-15
• Study First Submitted QC: 2022-01-21
• Study First Posted: 2022-02-03
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-24
• Last Update Posted: 2023-11-29
• Primary Completion: 2025-02-01
• Study Completion: 2025-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 570

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cardiac volumetric assessment 1	1 day	Left ventricular ejection fraction
Cardiac volumetric assessment 2	1 day	Left ventricular end-diastolic volume
Cardiac strain assessment 1	1 day	Left ventricular global longitudinal strain
Cardiac strain assessment 2	1 day	Left ventricular global circumferential strain
Cardiac volumetric assessment 4	1 day	Right ventricular ejection fraction
Cardiac volumetric assessment 3	1 day	Left ventricular myocardial mass
Cardiac volumetric assessment 5	1 day	Right ventricular end-diastolic volume

Secondary Outcome Measures

Name	Time	Method
Time	1 day	the time required for each scan under evaluation (real-time Cine and standard Cine)
Image quality assessment	1 day	Image quality of each scan component, assessed visually on a 4-point score - excellent (3), good (2), moderate (1) and poor (0).
Body-surface area	1 day	planimetered body-surface area

Trial Locations

Locations (1)

Glenfield Hospital; 🇬🇧 Leicester, Leics, United Kingdom