Near-infrared Spectroscopy Guided Percutaneous Coronary Intervention in Patients With Acute Myocardial Infarction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- Proportion of stent strut coverage
研究概览
简要总结
The aim of this study is to investigate whether near-infrared guided percutaneous coronary intervention in patients with acute myocardial infarction provides improved stent strut coverage at six months compared to conventionally angiography guided percutaneous coronary intervention.
详细描述
Background Myocardial infarction (MI) secondary to atherosclerotic coronary artery disease is mainly due to plaque-rupture with formation of a luminal thrombogenic material. Lesions responsible for MI are more frequently composed of lipid-rich plaques (LRP) in both culprit and in non-culprit lesions compared to lesions in patients with stable angina.
LRP is thought to be main precursor for future coronary events and may also have an impact on complications following percutaneous coronary intervention (PCI). It has been previously indicated that stent thrombosis (ST) and restenosis often occur when stenting a lipid-rich plaque. And if using angiography guidance only during PCI, there is a potential risk of implantation of a stent edge on a lipid pool, which can result in incomplete stent coverage of a lesion. The incidence of restenosis and ST may be related to the lesion characteristics, clinical presentation, antithrombotic treatment and stent design. Other factors may include inflammatory reaction to the polymer coating containing drug that delays vascular healing, insufficient stent strut coverage and incomplete stent apposition (ISA).
Invasive imaging modality can contribute to better understanding of the changes that occur in the vessel wall during stent implantation.
Intravascular ultrasound (IVUS) combined with a new imaging modality called near-infrared spectroscopy (NIRS) can identify LRP and provide a semi-quantitative estimate of amount of LRP present within selected region of interest. The method is excellent to identify ISA and improve stent implantation technique.
Optical coherence tomography (OCT) is a high resolution imaging modality that can analyze healing pattern after stent implantation such as stent strut coverage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Offline data analyzis are being performed without knowing which intervention group the patients are from
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with acute coronary syndrome (ST-elevation myocardial infarction and non-ST elevation myocardial infarction) referred for invasive coronary angiography and percutaneous coronary intervention at Department of Cardiology, Odense University Hospital (Odense, Denmark)
排除标准
- •participation in other randomized clinical trials
- •life expectancy < 1 year
- •allergy to aspirin, clopidogrel, ticagrelor or prasugrel
- •eGFR < 30 mL/min
- •tortuous and angiographically estimated extremely calcified lesions
- •ostial, left main and bifurcation lesions
- •lesions in a reference vessel diameter < 2.0 mm
- •hemodynamic instability
- •Scheduled for coronary artery bypass grafting
结局指标
主要结局
Proportion of stent strut coverage
时间窗: 6 months after index percutaneous coronary intervention
Proportion of stent strut coverage at 6 months follow up estimated by OCT
次要结局
- Persistent stent malapposition(6 months after index percutaneous coronary intervention)
- Uncovered stent struts(6 months after index percutaneous coronary intervention)
- Maximal neointimal growth(6 months after index percutaneous coronary intervention)
研究者
Manijeh Noori
MD; PhD-student
Odense University Hospital
