Clinical Value of Remote Ischemic Preconditioning

NCT ID: NCT01740102

Last Updated: 2016-08-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2013-09-30

Brief Summary

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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).

Detailed Description

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Conditions

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Heart Diseases Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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RIPC

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

Group Type EXPERIMENTAL

RIPC

Intervention Type PROCEDURE

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.

No RIPC

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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RIPC

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.

Intervention Type PROCEDURE

Other Intervention Names

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Remote ischemic preconditioning Ischemic preconditioning

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Helse Nord-Trøndelag HF

OTHER

Sponsor Role collaborator

Namsos Hospital

OTHER

Sponsor Role collaborator

Sykehuset Innlandet HF

OTHER

Sponsor Role collaborator

Helse Møre og Romsdal HF

OTHER_GOV

Sponsor Role collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alexander Wahba, MD prof

Role: STUDY_DIRECTOR

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

Lars Erik B Krogstad

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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St Olavs Hospital Trondheim University Hospital

Trondheim, , Norway

Site Status

Countries

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Norway

References

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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.

Reference Type RESULT
PMID: 25613907 (View on PubMed)

Other Identifiers

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2011/2525

Identifier Type: -

Identifier Source: org_study_id

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