Healthy VolunteersNORMAL MCMRNCT05066269
Normative Cardiovascular Magnetic Resonance Values for Measurement of Cardiovascular Structure and Function at MCMR
An observational study of Healthy Volunteers, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- How many people
- 122 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Oct 2021to 31 Dec 2022
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 120 healthy volunteers. separated into 12 equal sized groups. Groups will be separated by age and gender.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Manchester University NHS Foundation Trust
Manchester, Greater Manchester, M23 9LT
About this study
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.
Read more
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".
Read the detailed description
Cardiovascular magnetic resonance (CMR) has evolved into a gold standard non-invasive imaging tool in cardiovascular medicine, especially for visualising and quantifying cardiovascular anatomy and function, and evaluating heart muscle tissue character. It has unique capabilities in the diagnostic workup of patients with suspected cardiovascular disease, and for cardiovascular research, including disease characterisation and evaluation of interventions.
Measurements of cardiovascular structure and function can vary according to MRI scanner vendor, scanner field strength, imaging sequence and local patient population. The major Societies in the field, specifically the Society for Cardiovascular Magnetic Resonance (SCMR) and the European Association for Cardiovascular Imaging (EACVI), therefore state that local normal reference ranges for CMR measurements should be established. This will be a prospective, single-centre observational study in volunteers without a history of cardiovascular disease.
The British Heart Foundation Manchester Centre for Heart and Lung Magnetic Resonance Research (MCMR), based at Manchester University NHS Foundation Trust, is a recently-opened, state-of-the-art imaging centre. Greater Manchester has the highest rates of heart disease and lung disease in England, and the highest rate of premature cardiovascular death. The overall aims of MCMR are to facilitate cardiovascular and thoracic-related research in Manchester, in order to understand why people develop heart and lung disease, diagnose heart and lung disease at an earlier stage when it is more likely to be treatable, guide patient care more effectively and evaluate new treatments, so as to improve the length, and quality of life, of people living with, or at risk of, heart and lung disease.
- Conditions
- Healthy Volunteers
What is being measured
The primary outcome is the main question the study is designed to answer.
Normative Cardiac MRI values
Development of normative cardiac MRI values for MCMR unit.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2021
- Study start5 Oct 2021
- Primary completion4 Oct 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 122 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Manchester University NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Chris Miller, Principal investigator, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05066269
- Sponsor's protocol ID
- 21/WA/0272
- Other IDs
- B01254, 299730
- Acronym
- NORMAL MCMR
- Status last verified
- Mar 2023
- First submitted
- 23 Sep 2021
- Last updated
- 30 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Normative Cardiovascular Magnetic Resonance Values for Measurement of Cardiovascular Structure and Function at MCMR
- ClinicalTrials.gov ID
- NCT05066269
- Acronym / sponsor ID
- NORMAL MCMR / 21/WA/0272
- Conditions
- Healthy Volunteers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Manchester University NHS Foundation TrustOther government
- Study start
- 5 Oct 2021 (actual)
- Primary completion
- 4 Oct 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 4 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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".
Detailed description
Cardiovascular magnetic resonance (CMR) has evolved into a gold standard non-invasive imaging tool in cardiovascular medicine, especially for visualising and quantifying cardiovascular anatomy and function, and evaluating heart muscle tissue character. It has unique capabilities in the diagnostic workup of patients with suspected cardiovascular disease, and for cardiovascular research, including disease characterisation and evaluation of interventions.
Measurements of cardiovascular structure and function can vary according to MRI scanner vendor, scanner field strength, imaging sequence and local patient population. The major Societies in the field, specifically the Society for Cardiovascular Magnetic Resonance (SCMR) and the European Association for Cardiovascular Imaging (EACVI), therefore state that local normal reference ranges for CMR measurements should be established. This will be a prospective, single-centre observational study in volunteers without a history of cardiovascular disease.
The British Heart Foundation Manchester Centre for Heart and Lung Magnetic Resonance Research (MCMR), based at Manchester University NHS Foundation Trust, is a recently-opened, state-of-the-art imaging centre. Greater Manchester has the highest rates of heart disease and lung disease in England, and the highest rate of premature cardiovascular death. The overall aims of MCMR are to facilitate cardiovascular and thoracic-related research in Manchester, in order to understand why people develop heart and lung disease, diagnose heart and lung disease at an earlier stage when it is more likely to be treatable, guide patient care more effectively and evaluate new treatments, so as to improve the length, and quality of life, of people living with, or at risk of, heart and lung disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 120 healthy volunteers. separated into 12 equal sized groups. Groups will be separated by age and gender.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Normative Cardiac MRI values
Time frame: 1 year
Development of normative cardiac MRI values for MCMR unit.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2023.
- Individual participant dataSharing planned: No. 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.
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chris Miller principal investigator
University of Manchester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Volunteers, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Normative Cardiac MRI values (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2023.