Ischemia reperfusion injury sustained during coronary bypass surgery MedDRA version: 12.0 Level: LLT Classification code 10006894 Term: CABG MedDRA version: 12.0 Level: LLT Classification code 10051624 Term: Myocardial reperfusion injury
Conditions
Interventions
Trade Name: dipyridamole
Product Name: dipyridamole
Pharmaceutical Form: Capsule*
INN or Proposed INN: DIPYRIDAMOLE
CAS Number: 58-32-2
Concentration unit: mg milligram(s)
Concentration type: equal
C
Sponsors
RUNMC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Acceptation for CABG in RUNMC - Informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Recent myocardial infarction (STEMI or non-STEMI), during two weeks prior to inclusion - Asthma - 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) - Chronic or paroxysmal atrial fibrillation - Right ventricular failure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study the effect of oral pretreatment with dipyridamole on troponin-I release after CABG.;Primary end point(s): Troponin-I levels measured before and 6,12,24,48, and 72 hours after CABG.;Secondary Objective: To study whether oral pretreatment with dipyridamole reduces postoperative CABG arrhythmias, prolonged inotropic support, duration of ICU-stay, renal injury (assessing serum creatinine and biomarkers of renal injury: KIM-1 and SELDI-TOF analysis of urinary samples) and post-ischemic recovery of contractile function (measured ex-vivo). Furthermore we will test in this ex-vivo model whether a protective effect of dipyridamole on post-ischemic recovery of contractile function can be affected by caffeine administration. | — |
Countries
Netherlands
Outcome results
None listed