Clinical Value of Remote Ischemic Preconditioning

Study Overview
=================
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).

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

Conditions
-----------------
Heart Diseases, Atrial Fibrillation

Intervention / Treatment
-----------------
* Procedure: RIPC


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RIPC<br>Remote ischemic preconditioning (RIPC) in the operating theatre after induction of anaesthesia and before surgery. | Procedure: RIPC<br>* 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.<br>* Other names: Ischemic preconditioning;|
| No Intervention: No RIPC<br>Patients in the control group will not receive remote ischemic preconditioning before the surgery. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay |  | Maximum 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ischemic preconditioning, Coronary artery bypass, Preoperative care, Postoperative period