NCT01740102

Brief Summary

Objectives: Despite utilization of available means for cardioprotection during cardiac surgery, myocardial injury still occurs. Further improvement of cardioprotection is therefore necessary. Remote ischemic preconditioning (RIPC) is an easy and non-invasive method. Laboratory research has shown promising results regarding myocardial survival during open heart surgery, but the clinical value of RIPC is still largely unknown. The investigators hypothesize that RIPC before coronary artery bypass grafting (CABG) reduces the incidence of postoperative atrial fibrillation (POAF).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2012

Geographic Reach
1 country

1 active site

Status
completed

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

August 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 21, 2012

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 4, 2012

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

August 4, 2016

Status Verified

August 1, 2016

Enrollment Period

5 months

First QC Date

November 21, 2012

Last Update Submit

August 3, 2016

Conditions

Heart DiseasesAtrial Fibrillation

Keywords

Ischemic preconditioningCoronary artery bypassPreoperative carePostoperative period

Outcome Measures

Primary Outcomes (1)

  • Postoperative atrial fibrillation

    A patient will be classified as belonging to the postoperative atrial fibrillation group if they have any episode of atrial fibrillation, measured by telemetry, lasting more than 1 minute during their postoperative days at the hospital.

    Up to 10 days after surgery

Secondary Outcomes (1)

  • Length of hospital stay

    Maximum 14 days

Study Arms (2)

RIPC

EXPERIMENTAL

Remote ischemic preconditioning (RIPC) in the operating theatre after induction of anaesthesia and before surgery.

Procedure: RIPC

No RIPC

NO INTERVENTION

Patients in the control group will not receive remote ischemic preconditioning before the surgery.

Interventions

RIPCPROCEDURE

The remote ischemic preconditioning will consist of three sequential sphygmomanometer cuff inflations. The cuff will be inflated up to 200 mmHg for 5 minutes and then deflated for 5 minutes. This cycle will be performed three times in total. The entire preconditioning will therefore last for 25 minutes.

Also known as: Remote ischemic preconditioning, Ischemic preconditioning
RIPC

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elective isolated on-pump CABG surgery
  • Informed consent

You may not qualify if:

  • Patients with a severe pulmonary disease
  • Patients with renal failure (GFR\<30 mL/min/1.73 m2)
  • Patients with liver failure
  • Peripheral vascular disease affecting the upper limbs
  • Patients on sulfonylurea derivatives.
  • Patients with atrial fibrillation in their case history
  • Prior cardiac surgery (Re-operations)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Olavs Hospital Trondheim University Hospital

Trondheim, Norway

Location

Related Publications (1)

  • Krogstad LE, Slagsvold KH, Wahba A. Remote ischemic preconditioning and incidence of postoperative atrial fibrillation. Scand Cardiovasc J. 2015 Jun;49(3):117-22. doi: 10.3109/14017431.2015.1010565. Epub 2015 Feb 24.

    PMID: 25613907RESULT

MeSH Terms

Conditions

Heart DiseasesAtrial Fibrillation

Interventions

Ischemic Preconditioning

Condition Hierarchy (Ancestors)

Cardiovascular DiseasesArrhythmias, CardiacPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsInvestigative Techniques

Study Officials

  • Alexander Wahba, MD prof

    Faculty of Medicine Norwegian University of Science and Technology Trondheim, Norway, and Department of Cardiothoracic Surgery, St. Olavs Hospital, Trondheim, Norway.

    STUDY DIRECTOR

  • Lars Erik B Krogstad

    Faculty of Medicine Norwegian University of Science and Technology Trondheim, Norway.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2012

First Posted

December 4, 2012

Study Start

August 1, 2012

Primary Completion

January 1, 2013

Study Completion

September 1, 2013

Last Updated

August 4, 2016

Record last verified: 2016-08

Locations

NO(1)