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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 29, 2014