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Clinical Value of Remote Ischemic Preconditioning

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ClinicalTrials.gov Identifier: NCT01740102
Recruitment Status : Completed
First Posted : December 4, 2012
Last Update Posted : August 4, 2016
Sponsor:
Collaborators:
Information provided by (Responsible Party):

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).

Condition or disease Intervention/treatment
Heart Diseases Atrial Fibrillation Procedure: RIPC

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Does Remote Ischemic Preconditioning Reduce the Incidence of Postoperative Atrial Fibrillation in Patient Undergoing Coronary Artery Bypass Graft Surgery?
Study Start Date : August 2012
Primary Completion Date : January 2013
Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: RIPC
Remote ischemic preconditioning (RIPC) in the operating theatre after induction of anaesthesia and before surgery.
Procedure: 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.
Other Names:
  • Remote ischemic preconditioning
  • Ischemic preconditioning
No Intervention: No RIPC
Patients in the control group will not receive remote ischemic preconditioning before the surgery.


Outcome Measures

Primary Outcome Measures :
  1. Postoperative atrial fibrillation [ Time Frame: Up to 10 days after surgery ]
    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 :
  1. Length of hospital stay [ Time Frame: Maximum 14 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01740102


Locations
Norway
St Olavs Hospital Trondheim University Hospital
Trondheim, Norway
Sponsors and Collaborators
Norwegian University of Science and Technology
Levanger Hospital
Namsos Hospital
Sykehuset Innlandet HF
Helse Møre og Romsdal HF
Investigators
Study Director: 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.
Principal Investigator: Lars Erik B Krogstad Faculty of Medicine Norwegian University of Science and Technology Trondheim, Norway.
More Information

Publications:
Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01740102     History of Changes
Other Study ID Numbers: 2011/2525
First Posted: December 4, 2012    Key Record Dates
Last Update Posted: August 4, 2016
Last Verified: August 2016

Keywords provided by Norwegian University of Science and Technology:
Ischemic preconditioning
Coronary artery bypass
Preoperative care
Postoperative period

Additional relevant MeSH terms:
Atrial Fibrillation
Heart Diseases
Arrhythmias, Cardiac
Cardiovascular Diseases
Pathologic Processes