Cardiovascular Disease Clinical Trial
Official title:
Can Dipyridamole Induce Protection Against Ischemia and Reperfusion Injury in Patients Undergoing Elective CABG?
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.
n/a
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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