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临床试验/NCT02058771
NCT02058771Unknown不适用

ULTIMATE: Utilising Lifemap to Investigate Malignant Arrhythmia ThErapy

University Hospitals, Leicester1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2013年10月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
60
试验地点
1
主要终点
Ventricular arrhythmia/Sudden cardiac death

研究概览

简要总结

It is universally recognised that current methods for risk stratification of sudden cardiac death (SCD) are limited. A novel SCD risk marker, the Regional Restitution Instability Index (R2I2), measures the degree of heterogeneity in electrical restitution using data obtained from a standard 12 lead ECG acquired during an invasive electrophysiological study.

In an ischaemic cardiomyopathy (ICM) cohort of 66 patients, an R2I2 of ≥1.03 identified subjects with a significantly higher risk of ventricular arrhythmia (VA) or death (43%) compared with those with an R2I2 <1.03 (11%) (P=0.004).

This study will use non-invasive techniques to acquire electrical restitution data: exercise and pharmacological stress, and will incorporate body surface potential mapping to develop a non-invasive and high-resolution form of R2I2. Suitable patients will be recruited into a prospective, observational study.

HYPOTHESES:

PRIMARY:

  1. R2I2 is predictive of ventricular arrhythmia (VA) / SCD in patients with ICM.
  2. The exercise stress protocol will create a dynamic range of heart rates that allows ECG quantification of electrical restitution heterogeneity that correlates with invasive R2I2 and is predictive of VA/SCD. The pharmacological stress protocol will create a dynamic range of heart rates that allows ECG based quantification of electrical restitution heterogeneity that correlates with invasive R2I2 and is predictive of VA/SCD.

SECONDARY:

  1. A high-resolution electrical map acquired using body surface potential mapping will correlate with R2I2 and these data can be included in the R2I2 calculation to improve its prediction of SCD/VA.
  2. Serial measurement of R2I2 will produce consistent values.

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

  • History of ischaemic cardiomyopathy

排除标准

  • Unable to give informed consent
  • <28 days since cardiac surgery or acute coronary syndrome

结局指标

主要结局

Ventricular arrhythmia/Sudden cardiac death

时间窗: 18 months

次要结局

  • Syncope(18 months)
  • All cause mortality(18 months)

研究者

发起方
University Hospitals, Leicester
申办方类型
Other
责任方
Sponsor

研究点 (1)

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