NCT03159559Unknown4 期
A Randomized, Open-label Single-center Trial of Lipo-prostaglandin E1 Improves Coronary Microcirculation Dysfunction in Patients With Ischemic Heart Disease Combine With Diabetes Mellitus
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 60
- 主要终点
- myocardial perfusion reserve index (MPRI)
研究概览
简要总结
This study is undertaken to determine if intravenous Lipo-PGE1 therapy would improve coronary microvascular perfusion in patients with ischemic heart disease by CMRI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients giving written consent after being provided with sufficient explanation about participation in this clinical trial
- •Patients aged between 35-70, no limitation on gender
- •Patients with significant CAD and no need to PCI: 50%-70% luminal stenosis as determined by diagnostic coronary angiography, and left main coronary artery stenosis less than 50%; no history of revascularization procedures before
- •Type 2 DM patients with glycosylated hemoglobin levels>7%
- •All patients were PGE1-naive, defined as receiving no PGE1 therapy for more than 7 days during the previous 12 months
- •Hypertension remained stable for last 3 months, patients with controlled BP level: SBP<160mmHg and DBP<95mmHg
排除标准
- •Patients with a history of allergic to PGE1 or a history of prior PGE1 treatment.
- •History of revascularization procedures before: PCI or CABG
- •Patients with implanted pacemaker or ICD, ventricular assist device and intra-aortic balloon counter pulsation pump
- •Patients who have experienced myocardial infarction
- •Patients with serious systolic left ventricular function failure: echocardiography EF<25%
- •Claustrophobia
- •Patients who used Insulin pumps
- •SBP<90mmHg
- •Chronic renal function failure: creatinine level >2.5mg/dl or 221umol/l
- •Patients with serious or frequent arrhythmia ,atrial fibrillation、frequent ventricular premature contraction、sick sinus syndrome, second- or third degree atrioventricular block
- •Prior non-cardiac illness with estimated life expectancy <2-yrs
- •Women who are pregnant, lactation,or maybe pregnant in the study period
- •Unable to give informed consent
研究组 & 干预措施
Treatment group
Experimental
In the treatment group ,patients received conventional therapy plus Lipo-PGE1 10μg once daily intravenous injection for 7 days ;
干预措施: Lipo-PGE1 (Drug)
结局指标
主要结局
myocardial perfusion reserve index (MPRI)
时间窗: 1 week
次要结局
未报告次要终点
研究者
Dao Wen Wang
Chair of Internal medicine Dept. and Cardiovascular Division
Tongji Hospital
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