Can Dipyridamole Induce Protection Against Ischemia and Reperfusion Injury in Patients Undergoing Elective CABG?
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 95
- 试验地点
- 1
- 主要终点
- HS-troponin-I
研究概览
简要总结
Rationale:
Due to western lifestyle human coronary arteries are prone to develop atherosclerotic plaques. Hence the heart is an important target organ for atherothrombotic complications: myocardial ischemia, arrhythmias, myocardial infarction and heart failure. To alleviate symptoms and decrease mortality in these patients, myocardial revascularisation is recommended. Coronary artery bypass grafting (CABG) is indicated in patients with severe atherosclerotic disease of all three coronary arteries or the left main stem coronary artery. Cardiac ischemia and reperfusion injury during CABG is inevitable and jointly accountable for complications that occur after CABG (e.g. death, myocardial infarction, arrhythmias, stroke, or renal complications). Dipyridamole has been shown to reduce ischemia reperfusion injury in healthy volunteers using an intermediate endpoint and may prevent cardiovascular death or event in secondary prevention after cerebrovascular disease. The investigators hypothesise that oral pre-treatment with dipyridamole can increase cardiac tissue tolerance against ischemia and reperfusion injury due to CABG. The investigators expect lower troponin-I release in patients who were pretreated with dipyridamole.
Objective: To study the effect of oral pretreatment with dipyridamole on high sensitivity (HS)-troponin-I release after CABG. Secondary objectives are whether oral pretreatment with dipyridamole reduces postoperative CABG arrhythmias, prolonged inotropic support, and duration of Intensive Care-stay. Further secondary endpoints are the effects of dipyridamole pretreatment on renal injury and post-ischemic recovery of contractile function (measured ex-vivo).
Hypothesis:
The investigators hypothesize that oral pre-treatment with dipyridamole can increase cardiac tissue tolerance against ischemia and reperfusion injury. The investigators expect lower HS-troponin-I release in patients who were pretreated with dipyridamole. Additionally the investigators expect the incidence of arrhythmias, need for prolonged inotropic support (longer than 24 hours postoperative) to be decreased in pretreated patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acceptation for CABG in RUNMC
- •Informed consent
排除标准
- •Recent myocardial infarction (STEMI or non-STEMI), during two weeks prior to inclusion
- •Use of insulin
- •Use of sulfonylurea derivates (e.g. glibenclamide, tolbutamide, gliclazide, glimepiride)
- •Use of metformin
- •Use of oral corticosteroids
- •Use of dipyridamole
- •Use of clopidogrel within 8 days prior to scheduled CABG surgery
- •Chronic use of Non Steroid Anti-Inflammatory Drugs (NSAIDs)
- •Off-pump surgery
研究组 & 干预措施
placebo
干预措施: placebo (Drug)
dipyridamole
干预措施: Dipyridamole (Drug)
结局指标
主要结局
HS-troponin-I
时间窗: within 72 hours after CABG.
high sensitivity cardiac troponin-I
次要结局
- duration of IC stay(within three days after CABG)
- duration of inotropic support(within three days after CABG)
- drain production(24 hours after surgery and total drain production within three days after surgery)
- post-ischemic recovery of contractile function(until 4 hours after harvesting)
- Renal damage(Within three days after CABG)
研究者
G. Rongen
professor
Radboud University Medical Center