First-In-Human Intracoronary Dual-modal Optical Coherence Tomography and Fluorescence Lifetime Imaging (OCT-FLIM) In Patients Undergoing Percutaneous Coronary Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Fluorescence lifetime measurement of plaque inflammation in the target/culprit or non-target/non-culprit lesion (nanosecond)
研究概览
简要总结
Patients will undergo intracoronary imaging using combined optical coherence tomography-fluorescence lifetime imaging (OCT-FLIm) during percutaneous coronary intervention, and the obtained imaging data will be used to assess the efficacy of this dual-modal catheter imaging strategy in characterizing high-risk plaque.
详细描述
Fluorescence lifetime imaging (FLIm) is a novel imaging approach allowing label-free biochemical characterization of atherosclerotic plaque. A combined optical coherence tomography (OCT) and FLIm that can provide a simultaneous structural and biochemical assessment of atheroma has been constructed successfully. This study sought to investigate whether the dual-modal intravascular OCT-FLIm is able to characterize high-risk plaques in patients undergoing percutaneous coronary intervention.
Forty patients with multivessel coronary artery disease, who had at least one obstructive lesion (>70% diameter stenosis) that is considered suitable for PCI, will be included in the study. Culprit and mildly stenotic non-culprit plaques will be imaged using OCT-FLIm catheter.
Six-month follow-up assessment is systematically scheduled in all patients to assess temporal changes in FLIm signatures according to treatment strategies (medical therapy, interventional therapy etc).
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: greater than 20, less than 80
- •Patients with significant coronary artery disease (diameter stenosis >70%) requiring coronary revascularization
- •Reference vessel diameter: between 2.5 and 4.0 mm
- •Obtained informed consent from voluntary participants before study enrollment
排除标准
- •Complex coronary lesion (ostial lesion, unprotected left main lesion, chronic total occlusion, grafted vessels, etc)
- •Reference vessel diameter: less than 2.5 mm, greater than 4.0 mm
- •Coronary lesion with heavy calcification
- •Hemodynamic instability during coronary intervention
- •Contraindication to antithrombotic therapy
- •Chronic renal insufficiency (Serum creatinine >2.0mg/dL)
- •Severe liver dysfunction (AST/ALT > 5 times of upper normal limit)
- •Pregnancy or potential pregnancy
- •Life expectancy less than 1 year
- •Patient refused to sign the informed consent at enrollment
结局指标
主要结局
Fluorescence lifetime measurement of plaque inflammation in the target/culprit or non-target/non-culprit lesion (nanosecond)
时间窗: day 1
Difference in fluorescence lifetime measurement reflecting plaque inflammation according to pre-specified plaque subtypes
次要结局
- Fluorescence lifetime measurement of calcification in the target/culprit or non-target/non-culprit lesion (nanosecond)(day 1)
- Fluorescence lifetime measurement of healed plaque in the target/culprit or non-target/non-culprit lesion (nanosecond)(day 1)
研究者
Jin Won Kim
Jin Won Kim, MD, PhD
Korea University Guro Hospital