Clinical Value of Remote Ischemic Preconditioning

This study has been completed.
Sponsor:
Collaborators:
Levanger Hospital
Namsos Hospital
Sykehuset Innlandet HF
Helse Møre og Romsdal HF
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01740102
First received: November 21, 2012
Last updated: October 30, 2013
Last verified: October 2013
  Purpose

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 Intervention
Heart Diseases
Atrial Fibrillation
Procedure: RIPC

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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?

Resource links provided by NLM:


Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • Postoperative atrial fibrillation [ Time Frame: Up to 10 days after surgery ] [ Designated as safety issue: No ]
    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 [ Time Frame: Maximum 14 days ] [ Designated as safety issue: No ]

Enrollment: 92
Study Start Date: August 2012
Study Completion Date: September 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01740102     History of Changes
Other Study ID Numbers: 2011/2525
Study First Received: November 21, 2012
Last Updated: October 30, 2013
Health Authority: Norway:National Committee for Medical and Health Research Ethics

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

ClinicalTrials.gov processed this record on August 28, 2014