Atrial Fibrillation Clinical Trial
— RICOOfficial title:
A Clinical Study on the Effect of Remote Ischemic Conditioning on Atrial Fibrillation and Outcome After Coronary Artery Bypass Grafting
Verified date | January 2018 |
Source | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Netherlands | Academic Medical Center, University of Amsterdam | Amsterdam |
Lead Sponsor | Collaborator |
---|---|
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
Netherlands,
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 |
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