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临床试验/NCT05241184
NCT05241184Unknown不适用

Deriving Cardiac Reference Ranges at 3.0Tesla in Healthy Volunteers

University of Glasgow1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2021年11月10日最近更新:
适应症

试验速览

阶段
不适用
入组人数
32
试验地点
1
主要终点
Global and regional Circumferential strain (GCS)

研究概览

简要总结

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.

详细描述

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Sweden, 1.5T Siemens Avanto, 3.4 ± 0.7 ml/min/g [18] 2) Barts (London, UK) 3.0T Siemens Prisma, 3.00 +/-0.76 ml/g/min (unpublished data) and 3) Leeds, UK: 3.0T Siemens Prisma 2.89 ± 0.56 ml/g/min [19], 1.5T Philips Intera, 4.50 ± 0.91 ml/min/g[20] and studies are ongoing in sites such as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

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

结局指标

主要结局

Global and regional Circumferential strain (GCS)

时间窗: Through study completion, on average <2years.

using Displacement Encoding with Stimulated Echoes (DENSE) MRI.

Peak stress myocardial blood (mg/ml/min)

时间窗: Through study completion, on average <2years.

Peak stress myocardial blood with adenosine vasodilator stress

Myocardial perfusion reserve

时间窗: Through study completion, on average <2years.

Myocardial perfusion reserve with adenosine vasodilator stress

Global and septal T1 (MOLLI, shMOLLI) T2

时间窗: Through study completion, on average <2years.

reference ranges

Global and regional Longitudinal strain (GLS)

时间窗: Through study completion, on average <2years.

using Displacement Encoding with Stimulated Echoes (DENSE) MRI.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kenneth Mangion

Clinical Lecturer in Cardiology

University of Glasgow

研究点 (1)

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