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Deriving Cardiac Reference Ranges at 3.0Tesla in Healthy Volunteers

Deriving Cardiac Reference Ranges at 3.0Tesla in Healthy Volunteers

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05241184
Acronym
DECADENT-HV
Enrollment
32
Registered
2022-02-15
Start date
2021-11-10
Completion date
2022-10-01
Last updated
2022-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Keywords

cardiovascular magnetic resonance imaging, adenosine stress, parametric mapping, reference ranges, strain, healthy volunteers

Brief summary

Current MRI society guidelines recommend that reference ranges for specific imaging techniques (T1, T2 mapping, perfusion) are acquired on the MRI scanner that clinical work and research studies are being carried out on. We propose to undertake 32 multi parametric stress cardiac MRI scans on healthy volunteers (50% female, 50% male) over the age of 18 years. These measurements are not yet available for the 3.0T Prisma scanner at the Institute of Clinical Excellence (ICE), Queen Elizabeth University Hospital (QEUH). These values are essential to identify what is abnormal for people living in the west of Scotland.

Detailed description

Imaging societies recommend that each MRI scanner has a locally-derived reference range for tissue characteristics, notably the longitudinal (T1) and transverse (T2) myocardial relaxation times, measured in milliseconds \[16\]. T1 reference values vary according to the magnetic field strength of the MRI scanner. T1 and T2 times (ms) are expectedly higher at 3.0T compared to 1.5T, in line with results obtained when working with the Siemens VERIO scanner based at the BHF Glasgow Cardiovascular Research Centre \[17\]. T2 values for 3.0T are, generally, not so well described and are known to vary between different manufacturers and systems. A consensus statement by Society for Cardiovascular Magnetic Resonance (SCMR) endorsed by the European Association for Cardiovascular Imaging (EACVI) states that Reference ranges should be generated from data sets that were acquired, processed, and analyzed in the same way as the intended application, with the upper and lower range of normal defined by the mean plus and minus 2 standard deviations of the normal data, respectively.\[16\] Myocardial blood flow measurements for both stress and rest are also distinct for individual scanners, especially at 3.0T. In fact, a number of centres have derived site specific and magnet specific reference ranges from healthy volunteers including 1)Stockholm, Sweden, 1.5T Siemens Avanto, 3.4 ± 0.7 ml/min/g \[18\] 2) Barts (London, UK) 3.0T Siemens Prisma, 3.00 +/-0.76 ml/g/min (unpublished data) and 3) Leeds, UK: 3.0T Siemens Prisma 2.89 ± 0.56 ml/g/min \[19\], 1.5T Philips Intera, 4.50 ± 0.91 ml/min/g\[20\] and studies are ongoing in sites such as Oxford (https://www.ouh.nhs.uk/research/patients/trials/stress-mri.aspx) . As can be seen, there is a wide spread of values and local reference ranges are urgently required (defined as stress MBF \<2 standard deviations from the mean in healthy volunteers). These measurements are not yet available for the 3.0T Prisma scanner at the Institute of Clinical Excellence (ICE), Queen Elizabeth University Hospital (QEUH). These values are essential to identify what is abnormal for people living in the west of Scotland.

Interventions

DIAGNOSTIC_TESTMultiparametric stress CMR protocol

Multiparametric stress CMR protocol

Sponsors

NHS Greater Glasgow and Clyde
CollaboratorOTHER
University of Glasgow
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years

Inclusion criteria

* Age 18≥years * Capacity to provide written informed consent * Able to comply with study procedures * eGFR \>45ml/min * Vaccination status against SARS CoV-19 is not an exclusion criterion.

Exclusion criteria

* Contra-indication to CMR e.g. severe claustrophobia, metallic foreign body. * Contra-indication to intravenous adenosine, i.e. severe asthma; long QT syndrome; second- or third-degree AV block and sick sinus syndrome. * Lack of informed consent. * Women who are pregnant, breast-feeding or of child-bearing potential (WoCBP) without a negative pregnancy test * History of cardiovascular illness. * Previous COVID-19 illness

Design outcomes

Primary

MeasureTime frameDescription
Peak stress myocardial blood (mg/ml/min)Through study completion, on average <2years.Peak stress myocardial blood with adenosine vasodilator stress
Myocardial perfusion reserveThrough study completion, on average <2years.Myocardial perfusion reserve with adenosine vasodilator stress
Global and septal T1 (MOLLI, shMOLLI) T2Through study completion, on average <2years.reference ranges
Global and regional Circumferential strain (GCS)Through study completion, on average <2years.using Displacement Encoding with Stimulated Echoes (DENSE) MRI.
Global and regional Longitudinal strain (GLS)Through study completion, on average <2years.using Displacement Encoding with Stimulated Echoes (DENSE) MRI.

Countries

United Kingdom

Contacts

Primary ContactKenneth Mangion, MD PhD
kenneth.mangion@ggc.scot.nhs.uk0141 232 7600

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026