Real-time MRI for Evaluating Cardiac Volumetry

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.

Study Overview

• Status: Recruiting
• Conditions: Left Ventricle Abnormality
• Intervention / Treatment: Diagnostic test: cardiovascular magnetic resonance

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 Type: Observational
• Enrollment (Estimated): 570

Contacts and Locations

• Study Contact: Name: Jayanth Arnold, BMBCh; Phone Number: 01162583038; Email: jra14@le.ac.uk
• Study Contact Backup: Name: Mohamed Elshibly; Phone Number: 01162583038; Email: mmme1@le.ac.uk

Study Locations

• United Kingdom
  • Leics
    • Leicester, Leics, United Kingdom, LE3 9QP
      • Recruiting
      • Glenfield Hospital
      • Contact: Jayanth Arnold; Phone Number: 01162583038; Email: jra14@le.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adults patients referred for routine cardiac MRI at Glenfield Hospital.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time	the time required for each scan under evaluation (real-time Cine and standard Cine)	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).	1 day
Body-surface area	planimetered body-surface area	1 day

Collaborators and Investigators

• Sponsor: University of Leicester
• Investigators: Principal Investigator: Jayanth Arnold, University of Leicester

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2021
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: November 15, 2021
• First Submitted That Met QC Criteria: January 21, 2022
• First Posted (Actual): February 3, 2022

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 24, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: 0768; 270285 (Other Identifier: Health Research Authority)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: no plan to share data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No