Can dipyridamole induce protection against ischemia and reperfusion injury in patients undergoing elective CABG?

Conditions: Ischemia reperfusion injury sustained during coronary bypass surgery
MedDRA version: 12.0Level: LLTClassification code 10006894Term: CABG
MedDRA version: 12.0Level: LLTClassification code 10051624Term: Myocardial reperfusion injury

Registration Number: EUCTR2009-014299-22-NL

Lead Sponsor: RUNMC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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

-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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures