Remote Ischemic Conditioning and Atrial Fibrillation After Coronary Artery Bypass Grafting (CABG) (RICO)

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Status: Terminated

Conditions: Atrial Fibrillation

Treatments: Procedure: Sham; Procedure: Remote ischemic conditioning

Study type: Interventional

Funder types: Other

Identifiers

NCT01107184

NL 28041.018.09

Details and patient eligibility

About

Recent studies indicate that remote ischemic conditioning can protect the heart and other organs during cardiac surgery. The investigators aim to investigate whether such a stimulus can reduce the incidence of atrial fibrillation or other complications following coronary artery bypass surgery.

Enrollment: 191 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Elective on-pump CABG surgery
• 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

191 participants in 4 patient groups

Preconditioning

Experimental group

Description:

The remote ischemic stimulus will be applied after induction of anaesthesia, but before cardiopulmonary bypass.

Treatment:

Procedure: Remote ischemic conditioning

Postconditioning

Experimental group

Description:

The remote ischemic stimulus during cardiopulmonary bypass.

Treatment:

Procedure: Remote ischemic conditioning

Pre and postconditioning

Experimental group

Description:

The remote ischemic stimulus will be applied twice, after induction of anaesthesia and during cardiopulmonary bypass.

Treatment:

Procedure: Remote ischemic conditioning

Control

Sham Comparator group

Treatment:

Procedure: Sham