The aim of this clinical study is to investigate whether RIPC induced cardioprotection is associated with an increased amount of mitochondrial HK (mtHK) in the heart.
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 the HK mitochondrial binding ratio and
cardioprotection, evaluated by plasma cardiac troponin T (cTnT) values.
Secondary outcome
Secondary parameters are cytokine (IL-6, IL-10 and TNF-a) levels and inotropic
score. Furthermore CRP will be determined at the same time points as cTnT.
Background summary
Recent clinical data showed that remote ischemic preconditioning (RIPC)
attenuates myocardial damage in cardiac surgery. Although the exact mechanism
of RIPC, as well as clinical preconditioning (IPC), is not clear, several
pathways have been demonstrated to play a role in cardioprotection. There is
evidence that translocation of the glyocolytic enzyme hexokinase II (HKII) to
the mitochondria by activation of IPC-associated survival signalling protects
the heart against ischemia reperfusion injury. We want to investigate whether
RIPC induced cardioprotection is associated with an increased amount of
mitochondrial HK (mtHK). Furthermore, the promising role of cytokine IL-6 and
CRP release in RIPC will be studied.
Study objective
The aim of this clinical study is to investigate whether RIPC induced
cardioprotection is associated with an increased amount of mitochondrial HK
(mtHK) in the heart.
Study design
Single centre, randomized, double blind, prospective study.
Intervention
The RIPC protocol exists of 3*5 minutes of limb ischemia, induced by blood
pressure cuff inflation of the left upper arm. The first group will receive
this treatment after induction of anaesthesia, but before start of surgery
(RIPC). A second group will not receive RIPC and will serve as control group.
Study burden and risks
Patients will undergo 3*5 min of limb ischemia during surgery. This protocol
has been used safely in previous studies, and, with exception of one study,
showed preconditioning in patients undergoing CABG surgery. Possible benefits
of RIPC are a reduced release of troponin after surgery, which correlated well
with myocardial damage. Previous studies showed no adverse effects or harm of
this protocol. A tissue sample of the myocardium is taken during placement of
the cardiopulmonary bypass, ensuring that only tissue necessary for correct
placement of the cannula for extracorporeal circulation will be removed.
Additional blood samples (3 mL) will be taken before RIPC, 3 min after RIPC and
at 24 and 48 h after surgery for cTnT and cytokine determination.
meibergdreef 9
1105 AZ Amsterdam
NL
meibergdreef 9
1105 AZ Amsterdam
NL
Listed location countries
Age
Inclusion criteria
- Patients who have to undergo first time elective on-pump CABG without valve surgery
- older than 18 years
Exclusion criteria
- Diabetes or representing with hyperglycaemia (glucose > 8mM)
- increased preoperative cardiac troponin T values
- Unstable angina or angina within 48 hours before infarction
- Concomitant procedures
- Ejection fraction < 40%
- severe COPD
- SaO2 < 90% at room temperature
- Peripheral vascular disease affecting the upper limbs
- Nicorandil use
- Pre-/peri-operative morphin use
- women
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 | NL35879.018.11 |