Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05066269 |
| Other study ID # |
21/WA/0272 |
| Secondary ID |
B01254299730 |
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 5, 2021 |
| Est. completion date |
December 31, 2022 |
Study information
| Verified date |
March 2023 |
| Source |
Manchester University NHS Foundation Trust |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical 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. 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".
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.
