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

Atrial Fibrillation Clinical Trial

— RICO  

Official title:

A Clinical Study on the Effect of Remote Ischemic Conditioning on Atrial Fibrillation and Outcome After Coronary Artery Bypass Grafting

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01107184
• Other study ID #: NL 28041.018.09
• Status: Terminated
• Phase: N/A
• First received: April 19, 2010
• Last updated: January 30, 2018
• Start date: January 2010
• Est. completion date: February 2016

Study information

• Verified date: January 2018
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 191
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• Remote ischemic conditioning
Patients will have a automated inflator cuff placed on the upper arm during surgery. The cuff will be used to induce fore arm ischemia by inflation to 200 mmHg for 3 x 5 minutes, interspersed with 5 minutes of no-inflation and thus reperfusion.
• Sham
Patients will have a automated inflator cuff placed on the upper arm during surgery which will not be inflated.

Locations

Country	Name	City	State
Netherlands	Academic Medical Center, University of Amsterdam	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative atrial fibrillation		72 hours
Secondary	Major cardiovascular and cerebrovascular events	Major adverse events, i.e. death, acute coronary syndrome, stroke.	3 months, 6 months, 1 year
Secondary	Length of stay	Duration of hospitalization and stay on the ICU	1 week on avarage