跳至主要内容
临床试验/NCT05026112
NCT05026112招募中不适用

The Arrhythmogenic Potential of Midwall Septal Fibrosis in Dilated Cardiomyopathy: a Combined ECGI and CMR Investigative Study

University College, London1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2021年10月1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
120
试验地点
1
主要终点
The relationship between the electrical and structural substrate in DCM

研究概览

简要总结

Midwall septal fibrosis (MSF) is a common structural abnormality in non-ischaemic dilated cardiomyopathy (DCM). Its presence is believed to increase the risk of malignant ventricular arrhythmias (VA), but the mechanism of arrhythmogenicity is not known. This is particularly relevant in DCM patients with MSF and mid-range left ventricular ejection fraction (LVEF) as they do not currently fulfil criteria for a primary prevention implantable cardioverter-defibrillator (ICD) insertion.

Access to the epicardium for electrical measurements of the heart can enhance the understanding of arrhythmogenicity in DCM, however direct epicardial access is invasive. Instead, the investigators will non-invasively combine high resolution 256-lead ECG imaging (ECGI) and latest generation cardiovascular magnetic resonance (CMR) to study the hearts of 60 DCM patients with and without MSF regardless of LVEF, and 60 matched healthy volunteers. The investigators recently invented the re-usable and CMR-safe SMART-ECGI vest technology for this purpose. Using supercomputers, the investigators will fuse the collected ECGI/CMR data and run electromechanical simulations of whole-heart activation to non-invasively measure each participant's personalised risk of malignant VA induction.

By panoramically mapping the DCM heart in a single beat, the investigators aim to elucidate how MSF perturbs the cardiac activation front and how this could lead to life-threatening VA. This has the potential to change the method by which cardiologists risk stratify patients with DCM.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults with dilated cardiomyopathy
  • With and without midwall septal fibrosis on previous CMR

排除标准

  • Needle-phobic patients that would preclude cannulation for contrast injection and blood taking
  • anyone unwilling to consent
  • anyone with a conventional contraindication for CMR
  • anyone with any condition precluding full participation in the study such as DCM patients with infarct-pattern LGE, or subepicardial LGE or non-septal midwall fibrosis (participants with small volume right ventricular insertion point LGE will not be excluded).

结局指标

主要结局

The relationship between the electrical and structural substrate in DCM

时间窗: 2 years

The investigators will describe the relationship between the electrical and structural substrate in DCM across the spectrum of left ventricular dysfunction.

次要结局

  • Comparison of MSF+DCM, MSF-DCM and controls' electromechanical function of the heart via modelling(2 years)
  • Comparison of epicardial activation and conduction patterns via ECGI(2 years)
  • Personalised simulation of risk of malignant ventricular arrhythmia(2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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