The objective of this trial is to investigate whether remote ischemic preconditioning or remote ischemic postconditioning improves clinical outcome after coronary artery bypass grafting surgery, as measured by the incidence of postoperative atrial…
ID
Source
Brief title
Condition
- Coronary artery disorders
- Cardiac therapeutic procedures
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint will be the incidence of atrial fibrillation in the first
72 hours after surgery in each of the intervention groups as compared to
control.
Secondary outcome
Secondary endpoints will be the length of stay on the ICU and in the hospital,
the incidence of major cardiovascular events including death, rhythm
dissorders, heart failure, revascularisation, myocardial infarction, acute
coronary syndrome and stroke or transient ischemic attack after 30 days, 3
months and 1 year, in the intervention groups as compared to control.
Background summary
Recent clinical data showed that remote ischemic preconditioning protects the
myocardium against ischemia reperfusion damage in coronary artery bypass
grafting surgery (CABG). In animal experiments, also remote ischemic
postconditioning reduced infarct size. Atrial fibrillation is a common adverse
event after CABG and at least in part caused by ischemia reperfusion damage.
Atrial fibrillation is associated with worse outcome. We hypothesize that
remote ischemic pre- and postconditioning protects the heart against
ischemia-reperfusion damage and thereby reduces the incidence of atrial
fibrillation after CABG.
Study objective
The objective of this trial is to investigate whether remote ischemic
preconditioning or remote ischemic postconditioning improves clinical outcome
after coronary artery bypass grafting surgery, as measured by the incidence of
postoperative atrial fibrillation, the length of stay on the ICU and
in-hospital and the occurrence of major cardiovascular events at follow up.
Study design
A prospective patient and investigator blinded randomized controlled
multinational multicenter trial.
Intervention
Remote ischemic conditioning, consisting of 3 cycles of 5 minutes upper arm
ischemia followed by 5 minutes of reperfusion. One group will receive the
conditioning stimulus before aortic cross clamping (RIPC), a second group
during aortic cross clamping (Remote Post), a third group both before and
during aortic crossclamping (Pre/Post) and the fourth group will be the control
group, receiving no intervention.
Study burden and risks
All patients will follow the surgical and anaesthetic procedures as standard in
the respective hospital. In addition, the RIPC-, Remote Post- and
Pre/Post-group will receive a remote ischemic conditioning stimulus, which is a
safe intervention. Detection of postoperative atrial fibrillation will be done
using Holter-devices for 72 hours. Patients will be contacted to evaluate the
occurrence of major cardiovascular and cerebrovascular events at 30 days, 3
months and 1 year after surgery.
Postbus 22660
1100 DD Amsterdam
NL
Postbus 22660
1100 DD Amsterdam
NL
Listed location countries
Age
Inclusion criteria
Elective CABG surgery using extra corporeal circulation
Written informed consent
Exclusion criteria
Prior cardiac surgery (Re-operations)
Prior atrial fibrillation
Use of class 1 or 3 anti arrhythmic medication or digoxin
Use of intermittent aortic cross clamping during surgery
Age <18 years
Left ventricular ejection fraction *30%
Serious pulmonary disease (resting pO2 <90% at room air)
Renal failure (clearance <30 ml/min as calculated using the Modification of Diet in Renal Disease formula).
Liver failure
Use of the sulfonylurea derivative glibenclamide (this drug is known to block any preconditioning stimulus)
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 | NL28041.018.09 |