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

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ClinicalTrials.gov Identifier: NCT01107184
Recruitment Status : Terminated (slow recruitment)
First Posted : April 20, 2010
Last Update Posted : February 1, 2018
Sponsor:
Information provided by (Responsible Party):
B Preckel, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Procedure: Remote ischemic conditioning Procedure: Sham Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 191 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Clinical Study on the Effect of Remote Ischemic Conditioning on Atrial Fibrillation and Outcome After Coronary Artery Bypass Grafting
Study Start Date : January 2010
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Preconditioning
The remote ischemic stimulus will be applied after induction of anaesthesia, but before cardiopulmonary bypass.
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.
Other Names:
  • Remote ischemic preconditioning
  • Remote ischemic postconditioning
Experimental: Postconditioning
The remote ischemic stimulus during cardiopulmonary bypass.
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.
Other Names:
  • Remote ischemic preconditioning
  • Remote ischemic postconditioning
Experimental: Pre and postconditioning
The remote ischemic stimulus will be applied twice, after induction of anaesthesia and during cardiopulmonary bypass.
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.
Other Names:
  • Remote ischemic preconditioning
  • Remote ischemic postconditioning
Sham Comparator: Control Procedure: Sham
Patients will have a automated inflator cuff placed on the upper arm during surgery which will not be inflated.



Primary Outcome Measures :
  1. Post-operative atrial fibrillation [ Time Frame: 72 hours ]

Secondary Outcome Measures :
  1. Major cardiovascular and cerebrovascular events [ Time Frame: 3 months, 6 months, 1 year ]
    Major adverse events, i.e. death, acute coronary syndrome, stroke.

  2. Length of stay [ Time Frame: 1 week on avarage ]
    Duration of hospitalization and stay on the ICU



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01107184


Locations
Netherlands
Academic Medical Center, University of Amsterdam
Amsterdam, Netherlands
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Investigators
Principal Investigator: Stef de Hert, Md, PhD Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: B Preckel, Prof. dr. B. Preckel, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT01107184     History of Changes
Other Study ID Numbers: NL 28041.018.09
First Posted: April 20, 2010    Key Record Dates
Last Update Posted: February 1, 2018
Last Verified: January 2018

Keywords provided by B Preckel, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
Remote ischemic conditioning
CABG surgery
Atrial fibrillation
Coronary Artery Bypass
Ischemic Preconditioning

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes