Real-time MRI for Evaluating Cardiac Volumetry

NCT ID: NCT05221853

Last Updated: 2023-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

570 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-23

Study Completion Date

2025-02-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Left Ventricle Abnormality

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

cardiovascular magnetic resonance

CMR scan at 3 Tesla

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Leicester

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jayanth Arnold

Role: PRINCIPAL_INVESTIGATOR

University of Leicester

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Glenfield Hospital

Leicester, Leics, United Kingdom

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Jayanth Arnold, BMBCh

Role: CONTACT

01162583038

Mohamed Elshibly

Role: CONTACT

01162583038

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Jayanth Arnold

Role: primary

01162583038

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 40308862 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

270285

Identifier Type: OTHER

Identifier Source: secondary_id

0768

Identifier Type: -

Identifier Source: org_study_id