JPRN-jRCT1052180152招募中4 期
Observation of Coronary Atheroma Progression under Glucose Control with ConTInuous Glucose Monitoring GuidAnce in Patients with Type 2 Diabetes MeLlitus: Near-InfRared Spectroscopic Analysis - OPTIMAL-NIRS study
Kataoka Yu0 个研究点目标入组 90 人开始时间: 2019年3月25日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20age 至 80age（—）
- 性别
- All
入选标准
- •1. Male of female between 20 and 80 years of age
- •2. Type 2 diabetic patients with coronary artery disease
- •3. Subjects requiring PCI
- •4. The presence of mild stenosis in the non-target vessel (percent diameter
- •stenosis between 10-50%) identified by coronary angiography within 12 weeks prior to PCI
- •5. HbA1c betweeen 7.0% and 10.0%
- •6. HbA1c less than 10.0% in subjects who receive insulin, sulfonylurea or
- •nateglinide
- •7. Ability to understand the requirements of the study and to provide
- •informed consent
排除标准
- •1. very tortuous coronary artery and/or severe calcification which is unsuitable for
- •intravascular imaging
- •2. Subjects with severe renal dysfunction (estimated glomerular filtration rate < 40 mL/min/1.73m2)
- •3. the absence of any atherosclerotic lesions in the non-target vessel
- •4. those who take PCSK9 inhibitor
- •5. Pregnancy
- •6. Current enrolment in another investing device or drug study
- •7. unsuitable subject according to the investigator's discretion
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