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临床试验/NCT05841199
NCT05841199招募中不适用

Coronary Epicardial and Microcirculatory Determinants of Ventricular Tachycardia Tolerability

Imperial College London1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2023年8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
70
试验地点
1
主要终点
Change in blood pressure in participants before and after PCI

研究概览

简要总结

The goal of this observational study is to learn about the factors which determine how well ventricular tachycardia (VT) is tolerated. The main questions it aims to answer are:

  1. What impact does coronary artery disease have on the ability for a patient to tolerate VT?
  2. Does treatment of coronary artery disease with stents improve the tolerability of VT?

Participants who are undergoing a clinically indicated coronary angiogram or coronary angioplasty procedure will have measurements of blood pressure, coronary pressure and coronary flow made during pacing at a range of heart rates.

详细描述

Ventricular tachycardia (VT) is a common and life-threatening arrhythmia that occurs in people with heart problems. Some patients who develop this arrhythmia remain very stable with very little symptoms while others become unstable with low blood pressure or even sudden death. It is not known why some people tolerate the arrhythmia well and others do not.

If VT is not tolerated then current practice is to offer an implantable cardioverter defibrillator (ICD) which can deliver a shock to the heart if dangerous heart rhythms are detected. While shocks can be life-saving, they are also harmful, including causing psychological distress. ICDs also frequently deliver shocks when they are not needed.

If research could identify which factors predispose a person to be stable or unstable in VT, this would allow doctors to help them in a range of ways. One way would be to treat patients to improve the tolerance of VT, so avoiding the need for an ICD. Another would be to assess the the risk of instability and so allow a patient-centred decision on whether an ICD is needed.

In this study the investigators plan to recruit patients who are referred for a coronary angiogram. During the angiogram, the investigators will stimulate the heart at a range of fast heart rates and measure their blood pressure and flow in their coronary arteries. In patients who undergo stenting for a coronary stenosis, the investigators will also make these measurements after stenting so they can see if there is any difference. By recruiting a range of different cardiology patients, the investigators will be able to assess which factors contribute to stability during VT.

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

  • Able to give valid consent
  • Referred for coronary angiography or coronary angioplasty
  • Suitable for percutaneous physiological interrogation and PCI when clinically indicated

排除标准

  • Unable to give valid consent
  • Pregnant or breastfeeding women
  • Unstable coronary artery disease (acute coronary syndrome)
  • Severe multivessel coronary artery disease suitable for coronary artery bypass grafting
  • Severe heart valve disease
  • Severe (NYHA IV) heart failure

结局指标

主要结局

Change in blood pressure in participants before and after PCI

时间窗: At baseline and during simulated VT, immediately before PCI and after PCI

Change in coronary flow in participants with different levels of coronary microvascular function.

时间窗: At baseline and during simulated VT

Change in coronary flow in participants immediately before and after PCI

时间窗: At baseline and during simulated VT, immediately before PCI and after PCI

Change in blood pressure in participants with different levels of coronary microvascular function.

时间窗: At baseline and during simulated VT

次要结局

  • Change in blood pressure in participants with different levels of left ventricular function(At baseline and during simulated VT)
  • Change in coronary flow in participants with different levels of left ventricular function(At baseline and during simulated VT)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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