Clinical trial NCT05066269: Normative Cardiovascular Magnetic Resonance Values for Measurement of Cardiovascular Structure and Function at MCMR
Official title: Normative Cardiovascular Magnetic Resonance Values for Measurement of Cardiovascular Structure and Function at MCMR
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Volunteers
Lead sponsor: Manchester University NHS Foundation Trust
Sponsor class: OTHER_GOV
First posted: 2021-10-04
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 120 healthy volunteers. separated into 12 equal sized groups. Groups will be separated by age and gender.

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".

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.

Eligibility criteria: Inclusion Criteria:

1. Written, informed consent.
2. Aged 18 and over
3. 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.

Exclusion Criteria:

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

Primary outcomes:
measure: Normative Cardiac MRI values
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Manchester University NHS Foundation Trust
state: Greater Manchester
Study officials:
affiliation: University of Manchester
name: Chris Miller
role: PRINCIPAL_INVESTIGATOR
References: