search
Back to results

Clinical Value of Remote Ischemic Preconditioning

Primary Purpose

Heart Diseases, Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
RIPC
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Heart Diseases focused on measuring Ischemic preconditioning, Coronary artery bypass, Preoperative care, Postoperative period

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Elective isolated on-pump CABG surgery
  • Informed consent

Exclusion Criteria:

  • 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)

Sites / Locations

  • St Olavs Hospital Trondheim University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

RIPC

No RIPC

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Length of hospital stay

Full Information

First Posted
November 21, 2012
Last Updated
August 3, 2016
Sponsor
Norwegian University of Science and Technology
Collaborators
Helse Nord-Trøndelag HF, Namsos Hospital, Sykehuset Innlandet HF, Helse Møre og Romsdal HF
search

1. Study Identification

Unique Protocol Identification Number
NCT01740102
Brief Title
Clinical Value of Remote Ischemic Preconditioning
Official Title
Does Remote Ischemic Preconditioning Reduce the Incidence of Postoperative Atrial Fibrillation in Patient Undergoing Coronary Artery Bypass Graft Surgery?
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
Helse Nord-Trøndelag HF, Namsos Hospital, Sykehuset Innlandet HF, Helse Møre og Romsdal HF

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Diseases, Atrial Fibrillation
Keywords
Ischemic preconditioning, Coronary artery bypass, Preoperative care, Postoperative period

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RIPC
Arm Type
Experimental
Arm Description
Remote ischemic preconditioning (RIPC) in the operating theatre after induction of anaesthesia and before surgery.
Arm Title
No RIPC
Arm Type
No Intervention
Arm Description
Patients in the control group will not receive remote ischemic preconditioning before the surgery.
Intervention Type
Procedure
Intervention Name(s)
RIPC
Other Intervention Name(s)
Remote ischemic preconditioning, Ischemic preconditioning
Intervention Description
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.
Primary Outcome Measure Information:
Title
Postoperative atrial fibrillation
Description
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.
Time Frame
Up to 10 days after surgery
Secondary Outcome Measure Information:
Title
Length of hospital stay
Time Frame
Maximum 14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Elective isolated on-pump CABG surgery Informed consent Exclusion Criteria: 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander Wahba, MD prof
Organizational Affiliation
Faculty of Medicine Norwegian University of Science and Technology Trondheim, Norway, and Department of Cardiothoracic Surgery, St. Olavs Hospital, Trondheim, Norway.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Lars Erik B Krogstad
Organizational Affiliation
Faculty of Medicine Norwegian University of Science and Technology Trondheim, Norway.
Official's Role
Principal Investigator
Facility Information:
Facility Name
St Olavs Hospital Trondheim University Hospital
City
Trondheim
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
25613907
Citation
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.
Results Reference
result

Learn more about this trial

Clinical Value of Remote Ischemic Preconditioning

We'll reach out to this number within 24 hrs