Prediction of Atherosclerotic Plaque Progression in Patients With Acute Coronary Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Prediction of coronary atherosclerosis progression
研究概览
简要总结
To predict coronary atherosclerosis progression in patients with acute coronary syndrome by the use of intracoronary imaging methods.
To investigate the ability of NIRS to detect vulnerable plaque characterized by the presence of OCT-defined TCFA To study the influence of gene polymorphisms (in genes playing role in vessel dilatation) on the progression of coronary atherosclerosis and clinical outcomes
详细描述
The fundamental aim of this study is to investigate the ability of intracoronary imaging to predict progression of coronary atherosclerosis in patients with acute coronary syndrome. In patients who are indicated for acute coronary angiography and have at least one non-culprit lesion (not indicated for revascularization) identical segment of non-culprit vessel will be analysed and several parameters will be detected by OCT (optical coherence tomography) and NIRS (near-infrared spectroscopy) including the presence of TCFA (thin-cap fibroatheroma) and plaque lipid content quantified by LCBI (lipid core burden index). During follow up visits (1Y, 2Y, 5Y and 10Y) major cardiovascular events will be monitored and the progression of coronary involvement will be estimated at 1Y and 2Y by CCTA (coronary computed angiography).
The second part of the trial is to investigate the ability of NIRS to detect vulnerable plaque characterized by the presence of OCT-defined TCFA.
A further target is to study the influence of gene polymorphisms (in genes playing a role in vessel dilatation) on the progression of coronary atherosclerosis and clinical outcomes. Patient DNA will be isolated from peripheral blood leucocytes, and polymorphisms in genes for Hemoxygenase-1 and endothelial Nitric Oxide Synthase will be analysed.
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
- 否
入选标准
- •Acute coronary syndrome diagnosis
- •Presence of at least one non-culprit coronary lesion (not indicated for revascularisation)
排除标准
- •Contraindication for OCT or IVUS
- •Circulatory instability
- •Renal insufficiency (creatinine level >200umol/l)
- •Pregnant or of childbirth age and not using reliable contraception
- •Life expectancy of less than one year
结局指标
主要结局
Prediction of coronary atherosclerosis progression
时间窗: Two years from the date of cardiac catheterization
Prediction of coronary atherosclerosis progression (assesed by computed tomography, CT) in patients with acute coronary syndrome by the use of intracoronary imaging methods (OCT and NIRS)
次要结局
- Detection of vulnerable coronary atherosclerotic plaques by NIRS and OCT(Measured once at the time of cardiac catheterization.)
- Presence of gene polymorphisms(Analyzed once at the time of cardiac catheterization.)
研究者
Karel Kopriva
M.D
Na Homolce Hospital