NCT01107184

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
191

participants targeted

Target at P50-P75 for not_applicable atrial-fibrillation

Timeline
Completed

Started Jan 2010

Longer than P75 for not_applicable atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 19, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 20, 2010

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

February 1, 2018

Status Verified

January 1, 2018

Enrollment Period

6.1 years

First QC Date

April 19, 2010

Last Update Submit

January 30, 2018

Conditions

Atrial Fibrillation

Keywords

Remote ischemic conditioningCABG surgeryAtrial fibrillationCoronary Artery BypassIschemic Preconditioning

Outcome Measures

Primary Outcomes (1)

  • Post-operative atrial fibrillation

    72 hours

Secondary Outcomes (2)

  • Major cardiovascular and cerebrovascular events

    3 months, 6 months, 1 year

  • Length of stay

    1 week on avarage

Study Arms (4)

Preconditioning

EXPERIMENTAL

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

Procedure: Remote ischemic conditioning

Postconditioning

EXPERIMENTAL

The remote ischemic stimulus during cardiopulmonary bypass.

Procedure: Remote ischemic conditioning

Pre and postconditioning

EXPERIMENTAL

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

Procedure: Remote ischemic conditioning

Control

SHAM COMPARATOR
Procedure: Sham

Interventions

Remote ischemic conditioningPROCEDURE

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.

Also known as: Remote ischemic preconditioning, Remote ischemic postconditioning
PostconditioningPre and postconditioningPreconditioning
ShamPROCEDURE

Patients will have a automated inflator cuff placed on the upper arm during surgery which will not be inflated.

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elective on-pump CABG surgery
  • Informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Academic Medical Center, University of Amsterdam

Amsterdam, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 21605453DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Stef de Hert, Md, PhD

    Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. dr. B. Preckel

Study Record Dates

First Submitted

April 19, 2010

First Posted

April 20, 2010

Study Start

January 1, 2010

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

February 1, 2018

Record last verified: 2018-01

Locations

NL(1)