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A clinical study on the effect of Remote Ischemic Conditioning on atrial fibrillation and Outcome after coronary artery bypass grafting (RICO-trial)

A clinical study on the effect of Remote Ischemic Conditioning on atrial fibrillation and Outcome after coronary artery bypass grafting (RICO-trial) - RICO-trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON33030
Enrollment
300
Registered
2010-01-05
Start date
2010-01-01
Completion date
Unknown
Last updated
2024-05-06

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

Conditions

Coronary artery bypass grafting

Interventions

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 clampi

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Elective CABG surgery using extra corporeal circulation Written informed consent

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)