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

Primary Purpose

Atrial Fibrillation

Status
Terminated
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Remote ischemic conditioning
Sham
Sponsored by
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atrial Fibrillation focused on measuring Remote ischemic conditioning, CABG surgery, Atrial fibrillation, Coronary Artery Bypass, Ischemic Preconditioning

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Academic Medical Center, University of Amsterdam

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Sham Comparator

Arm Label

Preconditioning

Postconditioning

Pre and postconditioning

Control

Arm Description

The remote ischemic stimulus will be applied after induction of anaesthesia, but before cardiopulmonary bypass.

The remote ischemic stimulus during cardiopulmonary bypass.

The remote ischemic stimulus will be applied twice, after induction of anaesthesia and during cardiopulmonary bypass.

Outcomes

Primary Outcome Measures

Post-operative atrial fibrillation

Secondary Outcome Measures

Major cardiovascular and cerebrovascular events
Major adverse events, i.e. death, acute coronary syndrome, stroke.
Length of stay
Duration of hospitalization and stay on the ICU

Full Information

First Posted
April 19, 2010
Last Updated
January 30, 2018
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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1. Study Identification

Unique Protocol Identification Number
NCT01107184
Brief Title
Remote Ischemic Conditioning and Atrial Fibrillation After Coronary Artery Bypass Grafting (CABG)
Acronym
RICO
Official Title
A Clinical Study on the Effect of Remote Ischemic Conditioning on Atrial Fibrillation and Outcome After Coronary Artery Bypass Grafting
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Terminated
Why Stopped
slow recruitment
Study Start Date
January 2010 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Remote ischemic conditioning, CABG surgery, Atrial fibrillation, Coronary Artery Bypass, Ischemic Preconditioning

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
191 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Preconditioning
Arm Type
Experimental
Arm Description
The remote ischemic stimulus will be applied after induction of anaesthesia, but before cardiopulmonary bypass.
Arm Title
Postconditioning
Arm Type
Experimental
Arm Description
The remote ischemic stimulus during cardiopulmonary bypass.
Arm Title
Pre and postconditioning
Arm Type
Experimental
Arm Description
The remote ischemic stimulus will be applied twice, after induction of anaesthesia and during cardiopulmonary bypass.
Arm Title
Control
Arm Type
Sham Comparator
Intervention Type
Procedure
Intervention Name(s)
Remote ischemic conditioning
Other Intervention Name(s)
Remote ischemic preconditioning, Remote ischemic postconditioning
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Sham
Intervention Description
Patients will have a automated inflator cuff placed on the upper arm during surgery which will not be inflated.
Primary Outcome Measure Information:
Title
Post-operative atrial fibrillation
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
Major cardiovascular and cerebrovascular events
Description
Major adverse events, i.e. death, acute coronary syndrome, stroke.
Time Frame
3 months, 6 months, 1 year
Title
Length of stay
Description
Duration of hospitalization and stay on the ICU
Time Frame
1 week on avarage

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stef de Hert, Md, PhD
Organizational Affiliation
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Academic Medical Center, University of Amsterdam
City
Amsterdam
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
21605453
Citation
Brevoord D, Hollmann MW, De Hert SG, van Dongen EH, Heijnen BG, de Bruin A, Tolenaar N, Schlack WS, Weber NC, Dijkgraaf MG, de Groot JR, de Mol BA, Driessen AH, Momeni M, Wouters P, Bouchez S, Hofland J, Luthen C, Meijer-Treschan TA, Pannen BH, Preckel B. Effect of remote ischemic conditioning on atrial fibrillation and outcome after coronary artery bypass grafting (RICO-trial). BMC Anesthesiol. 2011 May 23;11:11. doi: 10.1186/1471-2253-11-11.
Results Reference
derived

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

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