Deriving Cardiac Reference Ranges at 3.0Tesla in Healthy Volunteers

Healthy Volunteers Clinical Trial

— DECADENT-HV  

Official title:

Deriving Cardiac Reference Ranges at 3.0Tesla in Healthy Volunteers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05241184
• Other study ID #: GN20CA408
• Status: Recruiting
• Start date: November 10, 2021
• Est. completion date: October 1, 2022

Study information

• Verified date: February 2022
• Source: University of Glasgow
• Contact: Kenneth Mangion, MD PhD
• Phone: 0141 232 7600
• Email: kenneth.mangion[@]ggc.scot.nhs.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: October 1, 2022
• Est. primary completion date: October 1, 2022
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Diagnostic Test:
• Multiparametric stress CMR protocol
Multiparametric stress CMR protocol

Locations

Country	Name	City	State
United Kingdom	Queen Elizabeth University Hospital	Glasgow	Lanarkshire

Sponsors (2)

Lead Sponsor	Collaborator
University of Glasgow	NHS Greater Glasgow and Clyde

Country where clinical trial is conducted

United Kingdom, 

Outcome

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