NCT05066269

Brief Summary

Cardiovascular magnetic resonance (CMR) imaging is an important clinical and research tool. Measurements of cardiovascular structure and function can vary according to scanner vendor, scanner field strength, imaging sequence and patient population. As such, the Society for Cardiovascular Magnetic Resonance (SCMR) and the European Association for Cardiovascular Imaging (EACVI) state that local normal reference ranges for CMR measurements should be established. This study plans to establish reference ranges for measurements of cardiovascular structure and function at the British Heart Foundation Manchester Centre for Heart and Lung Magnetic Resonance Research (MCMR). The work will underpin many other research projects and clinical practice. The study will involve volunteers having a CMR scan that will last around 30 minutes. No contrast agent will be administered. MRI scanning uses magnetic fields to make the pictures. The NHS website describes MRI scanning as "a painless and safe procedure" and "one of the safest medical procedures available".

Trial Health

87
On Track

Trial Health Score

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

Enrollment
122

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

September 23, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 4, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

October 5, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 4, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

March 30, 2023

Status Verified

March 1, 2023

Enrollment Period

12 months

First QC Date

September 23, 2021

Last Update Submit

March 29, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Normative Cardiac MRI values

    Development of normative cardiac MRI values for MCMR unit.

    1 year

Eligibility Criteria

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

120 healthy volunteers. separated into 12 equal sized groups. Groups will be separated by age and gender.

You may qualify if:

  • Written, informed consent.
  • Aged 18 and over
  • No known history of cardiovascular disease. It is recognised that it may be difficult to recruit older participants entirely free from cardiovascular disease, thus participants with relatively milder cardiovascular disease may be permitted, at the discretion of the investigator.

You may not qualify if:

  • Contraindication to MRI scanning, such as pacemaker, defibrillator, intraocular metal, prohibitive intracranial aneurysm clips or severe claustrophobia.
  • Unable to provide complete written or verbal consent in English.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Manchester University NHS Foundation Trust

Manchester, Greater Manchester, M23 9LT, United Kingdom

Location

Study Officials

  • Chris Miller

    University of Manchester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2021

First Posted

October 4, 2021

Study Start

October 5, 2021

Primary Completion

October 4, 2022

Study Completion

December 31, 2022

Last Updated

March 30, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

With participant consent, the pseudo-anonymised MRI scans and relevant data (such as age, sex, body surface area), may be shared with researchers in other hospitals and academic institutions. The code linking the participant number to the participant will be held at Manchester University NHS Foundation Trust and will not be shared.

Locations