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临床试验/NCT05221853
NCT05221853招募中不适用

Comparison of Standard Breath-hold Cardiac MRI With a Faster, Free-breathing Scan

University of Leicester1 个研究点 分布在 1 个国家目标入组 570 人开始时间: 2021年2月23日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
570
试验地点
1
主要终点
Cardiac volumetric assessment 1

研究概览

简要总结

This study will compare the accuracy of a real-time Cine sequence in assessing cardiac volumetry.

详细描述

This is a single-centre prospective study involving up to 570 patients with known or suspected cardiac disease referred for routine clinical cardiovascular magnetic resonance (CMR) assessment at Glenfield General Hospital, Leicester. In addition to standard multi-breath-hold steady-state free precession (SSFP) imaging (undertaken as part of the routine scan), each patient will also undergo additional imaging with a non-breath-hold multi-slice real-time cine sequence.

The primary outcome is the assessment of cardiac volumetry and function (end-diastolic volume, end-systolic volume, stroke volume, ejection fraction and myocardial mass) as measured by (1) the standard multi-breath-hold SSFP technique and (2) the non-breath-hold multi-slice real-time cine sequence. Secondary outcome measures will be (1) the time required for each scan, and (2) image quality for each scan. An additional secondary outcome will be to compare indexed cardiac volumes with those indexed according to measured body-surface area.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

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

入选标准

  • Patients aged ≥ 18 years
  • Referred for routine CMR imaging
  • Willing and able to give informed consent
  • Willing and able to comply with the requirements of the study
  • Able to understand written English

排除标准

  • Severe claustrophobia
  • Absolute contraindications to CMR (those with CMR conditional or safe devices will be eligible for inclusion)
  • Unable to provide informed consent
  • Participants unable to understand written English

结局指标

主要结局

Cardiac volumetric assessment 1

时间窗: 1 day

Left ventricular ejection fraction

Cardiac volumetric assessment 2

时间窗: 1 day

Left ventricular end-diastolic volume

Cardiac strain assessment 1

时间窗: 1 day

Left ventricular global longitudinal strain

Cardiac strain assessment 2

时间窗: 1 day

Left ventricular global circumferential strain

Cardiac volumetric assessment 4

时间窗: 1 day

Right ventricular ejection fraction

Cardiac volumetric assessment 3

时间窗: 1 day

Left ventricular myocardial mass

Cardiac volumetric assessment 5

时间窗: 1 day

Right ventricular end-diastolic volume

次要结局

  • Time(1 day)
  • Image quality assessment(1 day)
  • Body-surface area(1 day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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