Human Coronary Aspirate: Characterization of Particular and Soluble Substances and the Impact on Microvascular Obstruction
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Characterization of particular and soluble substances released during stenting into coronary aspirate and its vasoconstrictor potential.
研究概览
简要总结
During elective percutaneous coronary intervention (PCI), both proximal and distal protection devices are used. The distal occlusion protection device temporarily occludes the vessel distal to the lesion during the intervention, thereby capturing both particular debris and soluble substances released from the lesion such that they can be aspirated and prevented from reaching the coronary microcirculation. Rather than simply discarding the material which is retrieved from use of protection devices, the investigators have recently taken advantage of this situation, sampled the particulate and soluble material and subjected it to a variety of analyses with the ultimate goal to have a better insight into the respective plaque composition and to correlate it to the individual imaging and clinical data. On the basis of such information the investigators aim to better understand the pathophysiology of plaque vulnerability and to possibly predict the clinical development of the individual patient.
详细描述
Patients
- Symptomatic patients with a significant stenosis (diameter stenosis >75% or significant FFR) in a native coronary vessel or a saphenous vein aortocoronary bypass graft.
- All patients are on aspirin (100 mg/day) and received 10,000 I.U. heparin intravenously.
- Coronary angiography is performed via the femoral approach.
- Full informed consent are obtained from all patients before participating in the study.
Stenosis severity/Plaque composition
- Quantification of stenosis severity was performed with the use of off-line caliper measurements (QCA-MEDIS, Leiden, NL).
- Intravascular imaging analyses before and after stent implantation to characterize plaque morphology:
- IVUS(Eagle-EyeTM 20 MHz catheter and R-100 pullback device, Volcano Corporation, Rancho Cordova, CA, USA)
- OCT (St. Jude Medical Lightlab C7 Dragonfly Imaging Catheter)
- NIRS (InfraReDx TVC Insight catheter)
研究设计
- 研究类型
- Observational
- 时间视角
- Cross Sectional
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic patients with a significant stenosis (diameter stenosis >75% or significant FFR) in a native coronary vessel or a saphenous vein aortocoronary bypass graft
排除标准
- •Patients whereby a distal balloon occlusion devices is not applicable
结局指标
主要结局
Characterization of particular and soluble substances released during stenting into coronary aspirate and its vasoconstrictor potential.
时间窗: up to two years
* biochemical characterization: (quantification (as amount or concentration) of vasoconstrictive substances; cell fragments, proteins and lipids within the aspirate via HPLC, MS, or EIA Kits) * in vitro vasoconstriction, coronary microcirculation and cardiac contraction by aspirate (vasoconstriction detected as response of isolated arteries to aspirate normalized to that by KCl in a myograph; coronary microcirculation detected as coronary flow and cardiac contraction as left ventricular pressure within in the in vitro Langendorff heart model)
次要结局
- Correlation of characteristics of soluble and particular substances within aspirate to characteristics of coronary lesion and/or patients underlying disease(up to three years)
- Comparison of stenosis severity estimation using QCA and FFR versus IVUS, OCT and NIRS(up to one year)
研究者
Petra Kleinbongard
scientific assistant
Universität Duisburg-Essen