The aim of this clinical study is to investigate whether remote ischemic preconditioining induces an activation or phosphorylation of signalling pathway molecules (MAPK) in myocardium in patients undergoing coronary artery bypass graft (CABG)…
ID
Source
Brief title
Condition
- Coronary artery disorders
- Cardiac therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters are expression of signalling pathway proteins, detected
by molecular analysis from myocardial probes taken before and after RIPC
protocols during CABG surgery. ( PKC-*, p38MAPK, ERK and HSP27).
Secondary outcome
Ee will investigate standard hemodynamic parameters obtained during standard
cardiac surgery.
Background summary
Recent clinical data showed that remote ischemic preconditioning (RIPC)
attenuates myocardial damage in cardiac surgery. Although the exact mechanism
of remote ischemic preconditioning, as well as classical preconditioning, is
not clear, several pathways have been demonstrated to play a role transducing
cardioprotection. Among others, mitogen activated kinase pathway (MAPK) has
been shown to be involved. Supported by the evidence that remote ischemic
preconditioning is able to precondition human myocardium, we hypothesize that
this protection is mediated by regulation of expression of PKC-*, p38MAPK, ERK
and HSP27. We want to investigate this by molecular analysis of the
preconditioned myocardium in CABG patients
Study objective
The aim of this clinical study is to investigate whether remote ischemic
preconditioining induces an activation or phosphorylation of signalling pathway
molecules (MAPK) in myocardium in patients undergoing coronary artery bypass
graft (CABG) surgery.
Study design
Single center, randomized, patient and investigator blinded, prospective study
Intervention
The remote ischemic preconditioning protocol (RIPC) exist of 3* 5 minutes of
limb ischemia, induced by blood pressure cuff inflation of the upper arm. The
first group will undergo this regimen after induction of anesthesia, but before
start of the cardiopulmonary bypass to investigate molecular effects of
preconditioning (RIPC). A second group, without remote ischemia, will serve as
control group. Two additional groups with the same protocol will be performed
in patients with diabetes mellitus.
Study burden and risks
Patients will receive total intravenous anesthesia according to standard
anaesthetic procedures. The patients in the groups preconditioning will receive
3x5min ischemia of the non dominat upper arm followed by reperfusion. This
protocol has recently been tested in several clinical studies and has no known
side effects. Because of anesthesia no discomfort is to be expected.
Myocardial tissue samples will be obtained during placement of CPB, and no
extra tissue will be taken.
Meibergdreef 9
1100 DD Amsterdam
Nederland
Meibergdreef 9
1100 DD Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
>18 years, elective CABG surgery (with or without aortic valve surgery), written informed consent.
Exclusion criteria
<18 years, emergency operations, pregnancy, severe COPD, absent informed consent, SaO2<90% at room temperature, presumed non-cooperatives, legal incapacity, renal failure, liver failure
Design
Recruitment
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 |
|---|---|
| CCMO | NL22522.018.08 |