NCT05221853

Brief Summary

This study will compare the accuracy of a real-time Cine sequence in assessing cardiac volumetry.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
570

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 23, 2021

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 3, 2022

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

November 29, 2023

Status Verified

November 1, 2023

Enrollment Period

3.9 years

First QC Date

November 15, 2021

Last Update Submit

November 24, 2023

Conditions

Outcome Measures

Primary Outcomes (7)

  • 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 Outcomes (3)

  • Time

    1 day

  • Image quality assessment

    1 day

  • Body-surface area

    1 day

Interventions

CMR scan at 3 Tesla

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults patients referred for routine cardiac MRI at Glenfield Hospital.

You may qualify if:

  • 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

You may not qualify if:

  • Severe claustrophobia
  • Unable to provide informed consent
  • Participants unable to understand written English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Glenfield Hospital

Leicester, Leics, LE3 9QP, United Kingdom

RECRUITING

Related Publications (1)

  • 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.

Study Officials

  • Jayanth Arnold

    University of Leicester

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jayanth Arnold, BMBCh

CONTACT

Mohamed Elshibly

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2021

First Posted

February 3, 2022

Study Start

February 23, 2021

Primary Completion

February 1, 2025

Study Completion

February 1, 2025

Last Updated

November 29, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

no plan to share data

Locations