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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier:
NCT01107184
First received: April 19, 2010
Last updated: NA
Last verified: November 2009
History: No changes posted
  Purpose

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 Intervention Phase
Atrial Fibrillation
 Procedure: Remote ischemic conditioning
Procedure: Sham
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):

Primary Outcome Measures:
  • Post-operative atrial fibrillation [ Time Frame: 72 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Major cardiovascular and cerebrovascular events [ Time Frame: 3 months, 6 months, 1 year ] [ Designated as safety issue: No ]
    Major adverse events, i.e. death, acute coronary syndrome, stroke.

  • Length of stay [ Time Frame: 1 week on avarage ] [ Designated as safety issue: No ]
    Duration of hospitalization and stay on the ICU


Estimated Enrollment: 660
Study Start Date: January 2010
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 conditioning
  • 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 conditioning
  • 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 conditioning
  • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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)
  More Information

No publications provided

Responsible Party: Principal investigator: Prof. dr. S.G. de Hert, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT01107184     History of Changes
Other Study ID Numbers: NL 28041.018.09
Study First Received: April 19, 2010
Last Updated: April 19, 2010
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by 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
Ischemia
Arrhythmias, Cardiac
 Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013