NCT00622167终止不适用
Comparison of Dual Source Computed Tomography (DSCT) With Integrated Backscatter Intravascular Ultrasound (IB-IVUS) and Contrast Angiography in the Assessment of Coronary Artery Disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Comparison of Plaque Characteristics Between DSCT (Dual Source Computed Tomography) and IVUS (Intravascular Ultrasound).
研究概览
简要总结
The purpose of this study is to compare different methods of looking at atherosclerotic plaques in heart arteries. Identifying the characteristics of these plaques noninvasively would be very valuable. This study is looking at a new CT scanner (DSCT) to noninvasively image these plaques compared to invasive ultrasound (the current standard).
详细描述
The primary objectives of this study are:
- To compare with contrast angiography, the ability of DSCT to detect and quantify coronary artery stenoses.
- To compare with gray-scale IVUS, the ability of DSCT to quantify plaque cross-sectional diameter & area measurements & plaque volume.
- To evaluate the ability of DSCT to assess plaque morphology and quantify plaque components as compared to gray-scale and IB-IVUS.
- To evaluate the ability of DSCT to identify & measure lesion remodeling compared to gray-scale IVUS.
- To determine if pre-PCI evaluation of coronary plaque morphology by IB-IVUS can a) predict procedural success as assessed by adequate stent strut apposition and expansion and b) peri-procedural myocardial necrosis as measured by biomarker elevation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Males or non-pregnant females
- •> / = 18 years of age
- •Scheduled for coronary angiography
排除标准
- •Acute ST-elevation myocardial infarction within last 72 hours
- •Current congestive heart failure
- •Current cardiogenic shock
- •Unstable clinical condition
- •Known cardiomyopathy (EF < 30%)
- •Creatinine >1.5 mg/dL
- •Definite allergy to iodinated contrast media
- •Current participation in an investigational drug or device research study
- •HR > 65 and contraindications to the administration of beta blockers
- •Exclusion criteria assessed during catheterization procedure
- •PCI of native coronary vessel not performed
- •Left main stenosis > 50%
- •Any vessel contraindicated for IVUS imaging
- •Any lesion contraindicated for IVUS imaging
- •Inability to pass IVUS catheter
- •PCI of bifurcation lesion
结局指标
主要结局
Comparison of Plaque Characteristics Between DSCT (Dual Source Computed Tomography) and IVUS (Intravascular Ultrasound).
时间窗: At time of imaging
Characteristics include plaque cross-sectional diameter, area measurements, plaque volume, and plaque morphology (composition).
次要结局
未报告次要终点
研究者
Ik-Kyung Jang, MD, PhD
Professor of Medicine
Massachusetts General Hospital
研究点 (2)
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