A clinical study on the effect of Remote Ischemic Conditioning on atrial fibrillation and Outcome after coronary artery bypass grafting (RICO-trial)
- Conditions
- Coronary artery bypass grafting100110821000759310003216
- Registration Number
- NL-OMON33030
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 300
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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint will be the incidence of atrial fibrillation in the first<br /><br>72 hours after surgery in each of the intervention groups as compared to<br /><br>control. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints will be the length of stay on the ICU and in the hospital,<br /><br>the incidence of major cardiovascular events including death, rhythm<br /><br>dissorders, heart failure, revascularisation, myocardial infarction, acute<br /><br>coronary syndrome and stroke or transient ischemic attack after 30 days, 3<br /><br>months and 1 year, in the intervention groups as compared to control. </p><br>