Clinical Value of Remote Ischemic Preconditioning

Atrial Fibrillation Clinical Trial

Official title:

Does Remote Ischemic Preconditioning Reduce the Incidence of Postoperative Atrial Fibrillation in Patient Undergoing Coronary Artery Bypass Graft Surgery?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01740102
• Other study ID #: 2011/2525
• Status: Completed
• Phase: N/A
• First received: November 21, 2012
• Last updated: August 3, 2016
• Start date: August 2012
• Est. completion date: September 2013

Study information

• Verified date: August 2016
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: September 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Atrial Fibrillation
• Heart Diseases

Intervention

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.

Locations

Country	Name	City	State
Norway	St Olavs Hospital Trondheim University Hospital	Trondheim

Sponsors (5)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	Helse Møre og Romsdal HF, Levanger Hospital, Namsos Hospital, Sykehuset Innlandet HF

Country where clinical trial is conducted

Norway, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Length of hospital stay		Maximum 14 days	No