NCT01313533Unknown1 期
Biologically Modified Saphenous Vein Transplants for Improved CABG Outcomes
St. Luke's Hospital, Chesterfield, Missouri1 个研究点 分布在 1 个国家目标入组 540 人开始时间: 2015年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 540
- 试验地点
- 1
- 主要终点
- To study the effects of arginine on saphenous vein graft patency rates
研究概览
简要总结
The purpose of this study is to study the effects of polyarginine treated vein grafts on graft patency for patients undergoing coronary artery bypass surgery.
详细描述
Double blind study with Lactated Ringers Solution and Lactated Ringers Solution with Arginine soaked for 10 minutes prior to grafting on the coronary arteries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must be 25-95 years of age and able to give informed consent
- •Use of an approved statin and anti-platelet medication for at least 24 months.
- •Agreeable to Cardiovascular imaging at 12 months post-coronary artery bypass graft (CABG).
- •First time coronary artery bypass surgery,redo coronary artery bypass surgery and combined valve repair/replacement surgery and coronary artery bypass graft surgery are eligible to participate in study.
排除标准
- •Acute traumatic injury, vasculitis or planned concurrent ventricular surgical restoration, automatic implantable cardioverter defibrillators (AICD) placement or valvular surgery.
- •Hypercoaguable state.
- •Comorbid illness making 2 year survival unlikely.
- •Participation in another interventional investigative study of a cardiovascular drug or device within 30 days prior to CABG. May participate concurrently in other studies where the intervention/observation will not hinder execution of this study.
- •Patients with any medical condition that, in the investigator's judgment, makes the patient ineligible or places the patient at undue risk (e.g. conditions that preclude standard invasive follow up procedures such as angiography, i.e. renal failure, bleeding diathesis or peripheral vascular disease preventing catheterization via the groin).
- •Subject has clinical evidence of infection that the Investigator deems significant to the completion of the procedure or that could compromise the subject's safety.
- •Any patient was has undergone more than 20 computerized tomography (CAT) scans.
- •Any patient who is pregnant.
研究组 & 干预措施
Lactated Ringers Solution with Arginine
Active Comparator
100 ml of LRS with arginine
干预措施: Polyarginine (Drug)
Lactated Ringers Solution
Placebo Comparator
Lactated ringers solution
干预措施: Vein soak treated with Lactated Ringers Solution (Drug)
结局指标
主要结局
To study the effects of arginine on saphenous vein graft patency rates
时间窗: 12 months post operation
To study the effects of arginine on saphenous vein graft patency rates
次要结局
未报告次要终点
研究者
Ron Fiehler
Biologically Modified Saphenous Vein Transplants for Improved CABG Outcomes
St. Luke's Hospital, Chesterfield, Missouri
研究点 (1)
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