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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01107184
Acronym
RICO
Enrollment
191
Registered
2010-04-20
Start date
2010-01-31
Completion date
2016-02-29
Last updated
2018-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Keywords

Remote ischemic conditioning, CABG surgery, Atrial fibrillation, Coronary Artery Bypass, Ischemic Preconditioning

Brief 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.

Interventions

PROCEDURERemote 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.

PROCEDURESham

Patients will have a automated inflator cuff placed on the upper arm during surgery which will not be inflated.

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Post-operative atrial fibrillation72 hours

Secondary

MeasureTime frameDescription
Major cardiovascular and cerebrovascular events3 months, 6 months, 1 yearMajor adverse events, i.e. death, acute coronary syndrome, stroke.
Length of stay1 week on avarageDuration of hospitalization and stay on the ICU

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 29, 2026