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临床试验/NCT04258228
NCT04258228Unknown不适用

Trans-coronary Pacing to Assess Myocardial Viability

The Leeds Teaching Hospitals NHS Trust1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年10月28日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
50
试验地点
1
主要终点
Transcoronary mapping

研究概览

简要总结

Narrowing of the coronary arteries can cause chest pain and weaken the heart. In patients who have had heart attacks, blocked or severely narrowed arteries should be investigated (with coronary artery x-rays, or angiography) with efforts undertaken to improve the blood flow (angioplasty and stenting or heart bypass surgery). Sometimes these arteries are in fact supplying heart tissue which is already dead. Procedures to open up these vessels will therefore not influence how the patient feels or their future prognosis. On occasion, in order to determine whether heart tissue is alive (viable) and likely to benefit from of such efforts, a further investigation is required before another attempt is undertaken to open up these diseased arteries. This will require imaging of the heart to assess the state of the tissue (for example with magnetic resonance imaging, or cardiac MRI which is the gold standard). This means that patients may require two invasive procedures. One way around this would be to assess the electrical properties of the heart muscle in question during a single procedure. The principle is simply that dead muscle will have no electrical activity. Assessing the electrical properties of the heart through the coronary arteries using the same equipment used to treat the diseased artery during initial coronary angiography may provide viability information instantly, thus allowing treatment to proceed at the same procedure. In order to investigate whether this approach has promise, we will be performing a cardiac MRI around the time that patients have their coronary angioplasty. The electrical data will be compared to the cardiac MRI results to determine if this technique can be used in clinical practice. This innovative work has potential clinical and financial benefits.

Furthermore, patients can be diagnosed and treated during one procedure

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 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Out Patients over 18 years who have been listed for electively for percutaneous coronary intervention.
  • In Patients who have been admitted with an acute coronary syndrome undergoing angiography query proceed

排除标准

  • Patients deemed to be in the terminal stage of illness; and patients who are unable to give informed consent.
  • Atrial fibrillation with uncontrolled ventricular response at the time of procedure
  • The presence of a total occlusion of a coronary artery
  • Contra indications to coronary intervention
  • Patients with contraindications for cardiac MRI (See appendix) (15)
  • Patients with prior CABG
  • Patients who are claustrophobic
  • ST elevation myocardial infarction
  • Patients who have pace maker in situ
  • Patients on class I and III antiarrhythmics
  • Patients with haemodynamic instability

结局指标

主要结局

Transcoronary mapping

时间窗: 60 minutes

次要结局

未报告次要终点

研究者

发起方
The Leeds Teaching Hospitals NHS Trust
申办方类型
Other
责任方
Sponsor

研究点 (1)

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