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

Not Applicable

• Conditions: Acute Kidney Injury
• Interventions: Procedure: remote ischemic preconditioning (RIPC)

• Registration Number: NCT01827891
• Lead Sponsor: Beijing Anzhen Hospital

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.

Study Timeline

• Study Start: 2012-03
• Primary Completion: 2013-01
• Study First Submitted: 2013-03-31
• Status Verified: 2013-04
• Study First Submitted QC: 2013-04-09
• Last Update Submitted: 2013-04-09
• Study First Posted: 2013-04-10
• Last Update Posted: 2013-04-10
• Study Completion: 2013-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 310

Inclusion Criteria

• Patients with diabetes undergoing percutaneous coronary intervention were included.

Exclusion Criteria

1. emergency PCI,
2. baseline troponin value > 0.04 ng/mL,
3. nicorandil or glibenclamide use (preconditioning-mimetic and preconditioning-blocking medication, respectively),
4. patient on dialysis,
5. patients who had some inability to cooperate with the trial,
6. those who could not give informed consent, and (7) second procedure of staged elective PCI in this hospitalization.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
remote ischemic preconditioning (RIPC) group	remote ischemic preconditioning (RIPC)	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.

Primary Outcome Measures

Name	Time	Method
acute kidney injury	72 hours after procedure	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).

Secondary Outcome Measures

Name	Time	Method
relative reduction in estimated glomerular filtration rate	180 days after procedure	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.

Trial Locations

Locations (1)

Beijing Anzhen Hospital, Capital Medical University; 🇨🇳 Beijing, China