The Effect of Pioglitazone on Neointima Volume and Characteristics Observed by Optical Coherence Tomography (OCT)
研究概览
详细说明
People with diabetes mellitus are more prone to coronary heart disease, stroke, and peripheral vascular disease, and diabetes mellitus has been regarded as an independent risk factor for the progression of coronary artery disease. Several studies have been reported that diabetes increased the risk of cardiovascular mortality in both men and women. With the introduction of drug-eluting stents (DESs), the angiographic rates of restenosis at later months have reduced dramatically in several studies. However, even with DESs, diabetic patients showed increased rates of restenosis and late loss index compared with nondiabetic patients. Diabetes has been considered to be a predictor of poor prognosis after percutaneous coronary intervention with drug-eluting stents. Long-term clinical and angiographic outcomes after percutaneous coronary intervention (PCI) with drug-metal stents (DESs) have been demonstrated to be worse in diabetic patients compared with nondiabetic patients. In the era of DESs, no study has demonstrated the clinical and angiographic outcomes in diabetic patients after DES implantation by using optical coherence tomography (OCT).
Various microRNAs such as miRNA-21, -126, -143, -145 are involved in the restenosis and atherosclerosis progression (Figure 1). Changes in these miRNAs from baseline to 9 months after randomization have never been studied, and the effects of pioglitazone in correlation with the changes in various miRNAs could be utilized in clinical practices. Comparison of pioglitazone and placebo on 9 months follow-up neointima volume and neointima characteristics by optical coherence tomography (OCT) will be conducted.
研究类型
注册 (预期的)
阶段
- 第四阶段
联系人和位置
学习地点
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Seoul、大韩民国、136705
- Korea University Anam Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age: 18 years and above
- Gender eligible for study: both
- Diabetic patients either previously diagnosed or newly found diabetes.
- Fasting blood glucose ≥ 126 mg/dl or PP2 blood glucose ≥ 200 mg/dl for newly found diabetes.
- Patients with significant coronary artery disease (diameter stenosis > 70%) requiring stent implantation.
- Patients with informed consent.
Exclusion Criteria:
- Diabetic patients with the use of thiazolidinediones
- ACE inhibitor or ARB not allowed during the study period
- Previous history of PCI or bypass surgery
- Patients with any contraindications to the treatment of thiazolidinediones
- Pregnant or lactating patients
- Chronic alcohol or drug abuse
- Hepatic dysfunction
- Renal dysfunction
- Heart failure (EF < 50%)
- Expected life expectancy of < 1 year
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:Pioglitazone, Placebo
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Pioglitazone 15-30mg, once daily for 9 months
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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9 months follow-up neointima volume and neointima characteristics
大体时间:9 months follow-up
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Comparison of pioglitazone and placebo on 9 months follow-up neointima volume and neointima characteristics by optical coherence tomography (OCT).
Moreover, changes in miRNA-21.-126,
-143, -145 from baseline to 9 months will be compared.
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9 months follow-up
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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major adverse cardiovascular events
大体时间:9 months follow-up
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Comparison of pioglitazone and placebo on 9 months follow-up atheroma characteristics.
Moreover, major adverse cardiovascular events such as non-fatal MI, death, stroke, and TLR will be compared.
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9 months follow-up
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合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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