Assessment of Coronary Plaque Composition Using Optical Coherence Tomography During Chronic Inhibition of Lipoprotein-associated Phospholipase A2 (Lp-PLA2) Activity
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Quantification of plaque vulnerability.
研究概览
简要总结
The investigator's hypothesis is that local activation of the endogenous Lp-PLA2 plays an integral role in early atherosclerosis, and contributes to the mechanism of coronary endothelial dysfunction and to the structural and mechanical properties that characterize plaque vulnerability. Thus, the investigators study will characterize prospectively the correlation between the functional and structural vascular wall properties, and the activity of the Lp-PLA2 pathway.
详细描述
The present study was a substudy of our National Institute of Health (NIH) funded and Institutional Review Board (IRB) approved (08-008161) protocol "Lp-PLA2 and Coronary Atherosclerosis in Humans" and (10-000044) "Lp-PLA2 and Coronary Atherosclerosis in Humans Aim III" in which the investigators are examining the impact of long-term inhibition of Lp-PLA2, with a specific novel inhibitor, on Lp-PLA2 activity and improvement in coronary endothelial function.
This substudy will use Optical Coherence Tomography (OCT) to quantify alternate features of plaque vulnerability including superficial microcalcification, fibrous cap thickness, and plaque macrophage content at baseline and again at 6 months following Lp-PLA2 inhibition.
The study will provide insight into the role of the endogenous Lp-PLA2 in early coronary atherosclerosis, a potential therapeutic target for early coronary atherosclerosis in humans.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age > 18 years and < 85 years
- •referred to our cardiac catheterization laboratory for coronary vasomotion testing
- •are found to have coronary endothelial dysfunction.
排除标准
- •these include heart failure
- •ejection fraction < 40%
- •unstable angina
- •myocardial infarction or angioplasty within 6 months prior to entry into the study
- •use of investigational agents within 1 month of entry into the study,
- •patients who require treatment with positive inotropic agents other than digoxin during the study
- •patients with cerebrovascular accident within 6 months prior to entry the study
- •significant endocrine, hepatic or renal, disorders
- •local or systemic infectious disease within 4 weeks prior to entry into study
- •pregnancy or lactation
- •mental instability
- •Federal Medical Center inmates
研究组 & 干预措施
OCT at baseline
Subjects enrolled in the NIH funded and IRB approved (08-008161) protocol "Lp-PLA2 and Coronary Atherosclerosis in Humans" with a positive diagnosis of coronary artery endothelial dysfunction will be studied using Optical Coherence Tomography during the angiogram at baseline.
干预措施: Optical Coherence Tomography (C7 XR Dragonfly ) (Device)
OCT following 6 month Lp-PLa2 inhibition
Subjects who are enrolled in IRB 10-000044 "Lp-PLA2 and Coronary Atherosclerosis in Humans Aim III" a study in which the investigators are examining the impact of long-term inhibition of Lp-PLA2, with a specific novel inhibitor or placebo, on Lp-PLA2 activity and improvement in coronary endothelial function will be studied using Optical Coherence Tomography during the 6 month return angiogram.
干预措施: Optical Coherence Tomography (C7 XR Dragonfly ) (Device)
结局指标
主要结局
Quantification of plaque vulnerability.
时间窗: change from baseline to six months
Following recruitment of the total study population and 6-months therapy with the Lp-PLA2 inhibitor or placebo, using Optical Coherence Tomography (OCT) we will quantify alternate features of plaque vulnerability including superficial microcalcification, fibrous cap thickness, and plaque macrophage content comparing baseline and 6 months studies.
次要结局
未报告次要终点
研究者
Rajiv Gulati
MD Principal Investitgator
Mayo Clinic