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Completed

NCT Number: NCT05066269

Normative Cardiovascular Magnetic Resonance Values for Measurement of Cardiovascular Structure and Function at MCMR

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".

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Manchester University NHS Foundation Trust

Manchester, Greater Manchester, M23 9LT, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Normative Cardiac MRI values

    Time frame: 1 year

    Development of normative cardiac MRI values for MCMR unit.

Sponsors and collaborators

Lead sponsor

Manchester University NHS Foundation Trust

Other Gov

Registry information

Acronym: NORMAL MCMR

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 4, 2021
Registry last updated
Mar 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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