Remote Ischemic Preconditioning and Risk of Contrast-Induced Acute Kidney Injury in Patients Undergoing Coronary Stent Implantation

Study Overview
=================
Brief Summary
-----------------
This single-center, randomized controlled trial is to investigate the impact of remote ischemic preconditioning (RIPC) on the risk contrast-induced acute kidney injury and its long-term impact on renal function for patients with diabetes undergoing percutaneous coronary intervention.

Detailed Description
-----------------
Patients with diabetes undergoing elective percutaneous coronary intervention in Beijing Anzhen Hospital were enrolled, and all the eligible participants were randomized to either remote ischemic preconditioning (RIPC) group or control group. Those randomized to RIPC group had a pneumatic medical tourniquet cuff (width , 5 cm ; length , 40 cm) placed around their upper arm at < 2 hours before the PCI procedure. The pneumatic medical cuff was inflated to a pressure of 200 mm Hg for 5 minutes , followed by 5 minutes of deflation to allow reperfusion. This procedure was repeated for 3 times. Control participants did not experience this procedure of transient upper-limb ischemia.

Official Title
-----------------
Remote Ischemic Preconditioning and Risk of Contrast-Induced Acute Kidney Injury in Patients Undergoing Coronary Stent Implantation

Conditions
-----------------
Acute Kidney Injury

Intervention / Treatment
-----------------
* Procedure: remote ischemic preconditioning (RIPC)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with diabetes undergoing percutaneous coronary intervention were included. Exclusion Criteria: emergency PCI, baseline troponin value > 0.04 ng/mL, nicorandil or glibenclamide use (preconditioning-mimetic and preconditioning-blocking medication, respectively), patient on dialysis, patients who had some inability to cooperate with the trial, those who could not give informed consent, and (7) second procedure of staged elective PCI in this hospitalization.

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: control group<br>Control participants did not experience the procedure of transient upper-limb ischemia. | |
| Active Comparator: remote ischemic preconditioning (RIPC) group<br>Those randomized to RIPC group had a pneumatic medical tourniquet cuff (width , 5 cm ; length , 40 cm) placed around their upper arm at < 2 hours before the PCI procedure. The pneumatic medical cuff was inflated to a pressure of 200 mm Hg for 5 minutes , followed by 5 minutes of deflation to allow reperfusion. This procedure was repeated for 3 times. | Procedure: remote ischemic preconditioning (RIPC)<br>* Those randomized to RIPC group had a pneumatic medical tourniquet cuff (width , 5 cm ; length , 40 cm) placed around their upper arm at < 2 hours before the PCI procedure. The pneumatic medical cuff was inflated to a pressure of 200 mm Hg for 5 minutes , followed by 5 minutes of deflation to allow reperfusion. This procedure was repeated for 3 times.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| acute kidney injury | The primary study endpoint was AKI, defined as an absolute rise in serum creatinine of ≥ 0.5 mg/dl or a relative increase of ≥ 25% compared to baseline within 72 hours from PCI (the maximal measured concentration of serum creatinine during these 72 hours was used). | 72 hours after procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| relative reduction in estimated glomerular filtration rate | Secondary endpoints were the relative reduction in estimated glomerular filtration rate (eGFR) as well as all cause mortality, myocardial infarction and stent thrombosis at 30-day and 180-day after procedure. | 180 days after procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acute kidney injury, percutaneous coronary intervention, remote ischemic preconditioning