Deriving Cardiac Reference Ranges at 3.0Tesla in Healthy Volunteers

Study Overview
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Brief Summary
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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
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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Sweden, 1.5T Siemens Avanto, 3.4 ± 0.7 ml/min/g [18] 2) Barts (London, UK) 3.0T Siemens Prisma, 3.00 +/-0.76 ml/g/min (unpublished data) and 3) Leeds, UK: 3.0T Siemens Prisma 2.89 ± 0.56 ml/g/min [19], 1.5T Philips Intera, 4.50 ± 0.91 ml/min/g[20] and studies are ongoing in sites such as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.

Official Title
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Deriving Cardiac Reference Ranges at 3.0Tesla in Healthy Volunteers

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Diagnostic Test: Multiparametric stress CMR protocol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Multiparametric stress CMR protocol|Multiparametric stress CMR protocol|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak stress myocardial blood (mg/ml/min) | Peak stress myocardial blood with adenosine vasodilator stress | Through study completion, on average <2years. | 
| Myocardial perfusion reserve | Myocardial perfusion reserve with adenosine vasodilator stress | Through study completion, on average <2years. | 
| Global and septal T1 (MOLLI, shMOLLI) T2 | reference ranges | Through study completion, on average <2years. | 
| Global and regional Circumferential strain (GCS) | using Displacement Encoding with Stimulated Echoes (DENSE) MRI. | Through study completion, on average <2years. | 
| Global and regional Longitudinal strain (GLS) | using Displacement Encoding with Stimulated Echoes (DENSE) MRI. | Through study completion, on average <2years. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiovascular magnetic resonance imaging, adenosine stress, parametric mapping, reference ranges, strain, healthy volunteers