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临床试验/NCT02857790
NCT02857790已完成不适用

MRI Before and After Coronary Angioplasty With Rotational Atherectomy

NHS National Waiting Times Centre Board0 个研究点目标入组 58 人开始时间: 2012年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
58
主要终点
Change in circumferential myocardial strain

研究概览

简要总结

Percutaneous coronary intervention (PCI) with adjunctive high speed rotational atherectomy (HSRA) is commonly used to treat complex and calcified coronary artery stenoses. Theoretically, HSRA may have deleterious effects on the coronary microcirculation and result in peri-procedural myocardial infarction (Type 4a MI).

This study is assessing the effects of HSRA PCI using serial multi-parametric stress perfusion cardiac magnetic resonance imaging (CMR) (1.5 Tesla MAGNETOM Avanto, Siemens Healthcare). The study will prospectively enrol up to 75 patients (minimum completed cohort of 50 patients) undergoing elective HSRA PCI and performing multi-parametric CMR at 3 time-points: before HSRA, 1 week post-HSRA, and 6 months post-HSRA. Myocardial perfusion will be assessed using pharmacological stress with intravenous adenosine (140 micrograms/kg/min) at each time point. High-sensitivity cardiac troponin (hsTn) and ECGs will be performed post-HSRA.

详细描述

High Speed Rotational atherectomy (HSRA) is a technique used during angioplasty in the treatment of calcified coronary arteries. Rotablation debulks resistant calcium in the coronary artery plaque thus facilitating stent deployment and expansion. The atherectomy technique involves a rotating diamond-tipped burr which breaks down the calcium into small particles which are washed forward by the blood flow into the smaller coronary branches supplying the heart muscle. The dispersed calcium particles may block these smaller blood vessels, interrupting blood flow to an extent that may result in heart muscle damage. When this injury becomes detectable clinically, with symptoms, ECG changes and increased troponin, an iatrogenic type IV myocardial infarction (MI) is diagnosed.

Cardiac magnetic resonance imaging (CMR) is the gold standard method for imaging the heart providing detailed information on cardiac function and muscle injury.

This is a prospective cohort observational study of 60 patients undergoing coronary angioplasty with rotational atherectomy.

The aim of the study is to investigate myocardial injury revealed by paired CMR scans before and after rotational atherectomy.

The hypothesis is that following rotational atherectomy, displacement of calcified particles cause microvascular obstruction leading to reduced perfusion. Since myocardial perfusion and pump function are linked, as myocardial perfusion is reduced after atherectomy, so myocardial contractility (i.e. strain) will reduce. In a second analysis, computer modelling will be used to integrate the different types of CMR information to better understand the spatial, temporal and pathological evolution of myocardial infarction (www.softmech.org). The further hypothesis is that despite CMR detectable infarction the incidence of clinical type IV MI will be low.

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

  • Stable angina
  • Indication for PCI with rotablation

排除标准

  • Other major systemic illness
  • Contra-indication to CMR
  • Pregnancy
  • CKD (eGFR<30)
  • Pre-existing infarct in culprit vessel territory on ECG, echo or baseline CMR
  • Chronic total occlusion

结局指标

主要结局

Change in circumferential myocardial strain

时间窗: 1 week and 6 months post-rotablation

次要结局

  • Incidence of CMR detected de novo late gadolinium enhancement(1 week and 6 months post-rotablation)
  • Incidence of type IV myocardial infarction(6-12 hours post-rotablation)
  • Change in ischaemic burden(1 week and 6 months post-rotablation)
  • Index of Microcirculatory Resistance (IMR)(Intra-procedural baseline, intra-procedural post-rotablation, and intra-procedural post-stenting)
  • Change in left ventricular ejection fraction (LVEF)(1 week and 6 months post-rotablation)
  • Change in left ventricular (LV) volumes(1 week and 6 months post-rotablation)
  • Minimum Stent Area (MSA)(Intra-procedural post-rotablation)

研究者

发起方
NHS National Waiting Times Centre Board
申办方类型
Other
责任方
Principal Investigator
主要研究者

Margaret McEntegart

Consultant Cardiologist

NHS National Waiting Times Centre Board

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