NCT01506960终止4 期
Evaluation of a Combined Near Infrared Spectroscopy (NIRS) and Intravascular Ultrasound (IVUS) Catheter for Detection of Lipid Rich Plaque
适应症
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Detection of Lipid Rich Plaque by Near Infrared Spectroscopy (NIRS) Intravascular Ultrasound (IVUS)
研究概览
简要总结
The purpose of this study is to learn more about lipid rich plaque using Near Infrared Spectroscopy (NIRS)/Intravascular Ultrasound (IVUS) imaging in patients who have had coronary artery stenting and Optical coherence tomography (OCT) imaging.
详细描述
The aims of this study are to:
- Test the ability of the new NIRS IVUS system to detect lipid pool
- Evaluate the accuracy of the NIRS IVUS system for localization of lipide rich plaque: superficial vs deep
- Improve diagnostic accuracy of OCT for detection of lipid using information from NIRS IVUS
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 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient Characteristics
- •Males and non-pregnant females > 18 and < 79 years of age
- •Patients referred for diagnostic coronary angiography who are found to have lesions in native coronary arteries which will be treated by percutaneous coronary intervention (PCI) (or patients with known coronary lesions who are referred for planned PCI)
- •Able to give written informed consent
- •Lesion Characteristics
- •Lesion in native coronary artery
- •Angiographic stenosis > 50%
- •Reference vessel diameter 2.5 mm - 4.0 mm by visual estimation
- •Subjects who have successful PCI and OCT
- •General Exclusion Criteria
- •Subjects who are unable or unwilling to sign the informed consent form
- •Subjects with serious co-morbid conditions that in judgment of the investigator preclude inclusion in this study (such as terminal cancer, life expectancy < 6 months, Liver Function Tests (LFTs) > 3 times Upper Limit of Normal (ULN), or post-transplant)
- •Subjects with New York Heart Association (NYHA) class III or IV heart failure or known left ventricular ejection fraction < 30%
- •Subjects who have experienced an ST-elevation myocardial infarction (STEMI) within 72 hours prior to the procedure
- •Subjects with hemodynamic or electrical instability (including shock)
- •Subjects diagnosed with severe, non-catheter-related coronary artery spasm
- •Subjects who are or may be pregnant
- •Subjects with known allergies to contrast media
- •Subjects with renal failure as defined by estimated Glomerular Filtration Rate (eGFR) <
- •History of Transient Ischemic Attack (TIA) or stroke < 6 months
- •Lesion Specific Exclusion Criteria These exclusion criteria apply to the target lesion to be imaged by NIRS IVUS.
- •Lesion located in the left main coronary artery
- •Lesions that are heavily calcified
- •Lesions where OCT cannot be performed due to technical difficulties
- •Other lesions that the investigator deems inappropriate for the procedure such as lesions with excessive tortuosity, presence of thrombus, low flow by TIMI grade.
排除标准
- 未提供
结局指标
主要结局
Detection of Lipid Rich Plaque by Near Infrared Spectroscopy (NIRS) Intravascular Ultrasound (IVUS)
时间窗: Measured one point in time during cardiac catheterization
Subjects are presenting for their clinically-indicated cardiac catheterization. NIRS/IVUS imaging will be done at the time of catheterization.
次要结局
- Differences in NIRS Parameters Between Deep and Superficial Lipid Assessed by Optical Coherence Tomography (OCT).(Measured at the time of cardiac catheterization)
研究者
Ik-Kyung Jang, MD, PhD
Professor of Medicine
Massachusetts General Hospital
研究点 (2)
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