To study the effect of oral pretreatment with dipyridamole on troponin-I release after CABG. Secondary objectives are whether oral pretreatment with dipyridamole reduces postoperative CABG arrhythmias, prolonged inotropic support, and duration of…
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Troponin-I levels measured before and 6,12,24,48, and 72 hours after CABG.
Secondary outcome
Incidence of arrhythmias, need for prolonged inotropic support (longer than 24
hours postoperative), prolonged ICU stay (longer than 24 hours). Biomarkers in
renal injury (serum creatinine, KIM-1 and SELDI-TOF analysis of urinary
samples).
Post-ischemic recovery of contractile function in our atrial trabeculae model.
Background summary
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 bypass
surgery (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 TIA or CVA. We hypothesise that oral pre-treatment
with dipyridamole can increase cardiac tissue tolerance against ischemia and
reperfusion injury due to CABG. We expect lower troponin-I release in patients
who were pretreated with dipyridamole.
Study objective
To study the effect of oral pretreatment with dipyridamole on troponin-I
release after CABG. Secondary objectives are whether oral pretreatment with
dipyridamole reduces postoperative CABG arrhythmias, prolonged inotropic
support, and duration of ICU-stay. Further secondary endpoints are the effects
of dipyridamole pretreatment on renal injury and post-ischemic recovery of
contractile function (measured ex-vivo).
Study design
Randomised double blind, placebo controlled clinical trial.
Intervention
pretreatment with dipyridamole (Persantin Retard) 2dd 200mg or placebo
Study burden and risks
This study will be executed at the Radboud University Nijmegen Medical Centre
under close medical supervision. Treatment with dipyridamole or placebo is not
expected to harm the participants. Dipyridamole may marginally increase the
risk of bleeding complications.
postbus 9101
6500 HB Nijmegen
NL
postbus 9101
6500 HB Nijmegen
NL
Listed location countries
Age
Inclusion criteria
- Acceptation for CABG in RUNMC
- Informed consent
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)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2009-014299-22-NL |
| CCMO | NL28900.091.09 |