Prevalence of Vulnerable Plaque Its Location and Clinical Significance in Bifurcation Lesions Detected by Optical Coherence Tomography.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 304
- 试验地点
- 1
- 主要终点
- The prevalence of coronary vulnerable plaques in bifurcation lesions using coherence tomography (OCT)
研究概览
简要总结
To determine the clinical prevalence of vulnerable plaque using OCT in patients with coronary bifurcation lesion.
详细描述
This is a prospective registry study in which patient with bifurcation lesion undergoing baseline coronary angiography, baseline OCT and percutaneous coronary intervention will be studied. OCT is used to assess the prevalence of vulnerable plaque, its location at bifurcation lesions and compare vulnerable plaque related major adverse cardiovascular events (MACE) during one-year follow-up in bifurcation lesions between patients with vulnerable plaque and those without. Relationship between endothelial shear stress and vulnerable plaque. Relationship between bifurcation angle and vulnerable plaque.
Group A: presence of vulnerable plaque at the bifurcation Group B: absence of vulnerable plaque at the bifurcation Documentation of immediate post stent OCT and 12 months follow up angiography with OCT will be performed. Immediate post stent OCT to assess successful stent implantation and after 12 months follow up to document year major adverse cardiovascular events (MACE) included myocardial infraction, cardiac death and clinically driven target lesion revascularization, stent thrombosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥ 18 years old
- •Patients with ischemic heart disease who are considered for coronary revascularization with PCI
- •True coronary bifurcation lesion Medina 1.1.1, 0.1.1, 1.0.1 (stenosis> 50% by visual estimation) treated by drug-eluting stent
- •Reference vessel diameter of main vessel >= 2.5mm and side branch >=2.0 mm by visual estimation
排除标准
- •Saphenous vein grafts
- •In-stent restenotic lesions
- •Thombus-containing lesions
- •Patient who had Myocardial infarction with in less than one month
- •Patent who had bifurcation lesion dilation with balloon
- •Contraindication or hypersensitivity to anti-platelet agents or contrast media
- •Creatinine level ≥ 2.0 mg/dL
- •Severe hepatic dysfunction (3 times normal reference values)
- •Hemodynamic unstable patients
- •Inability of OCT devise to cross the lesion into distal vessel
- •Pregnant women or women with potential childbearing
- •Inability to understand or read the informed content
研究组 & 干预措施
Vulnerable plaque
Thin-cap fibro atheroma (TCFA) was defined as a lipid-rich plaque with the thinnest fibrous cap thickness<65um. Plaque rupture was identified by the presence of fibrous cap discontinuity with a clear cavity formation inside the plaque. Plaque erosion is characterized by luminal thrombus and absence of the endothelium or without evidence of fibrous cap disruption. Fibro calcific plaque contains OCT evidence of fibrous tissue along with calcium that appears as a signal-poor or heterogeneous region with a sharply delineated border which is applied to larger calcifications. Calcified nodule is characterized as a signal or multiple regions of calcium protruding into the lumen, superficial calcification accompanied by substantive calcium proximal and or distal to the lesion. Thrombus is defined as a mass attached to luminal surface or floating within the lumen. It is seen as a protrusion inside the lumen of the artery with signal attenuation.
干预措施: percutaneous coronary intervention (Procedure)
Without any vulnerable plaqueStable plaque
patient with bifurcation lesion undergoing baseline coronary angiography and baseline OCT.
干预措施: percutaneous coronary intervention (Procedure)
结局指标
主要结局
The prevalence of coronary vulnerable plaques in bifurcation lesions using coherence tomography (OCT)
时间窗: Documentation of baseline OCT
Vulnerable plaque was considered when presence of Thin-cap fibro atheroma (TCFA), Lipid-rich plaque (vulnerable), Plaque rupture, Plaque erosion, thrombus and calcified nodule.
次要结局
- Major Adverse Cardiovascular Events (MACE)(0 to 12 months)
- Thin-cap fibroatheroma(0 to 12 months)
- Calcified nodule(0 to 12 months)
- Plaque erosion(0 to 12 months)
- Plaque rupture(0 to 12 months)
- Stent Thrombosis(0 to 12 months)
- Thrombus(0 to 12 months)
研究者
Shaoliang Chen
Vice President
Nanjing First Hospital, Nanjing Medical University