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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Beijing Anzhen Hospital

Current Primary Outcome: acute kidney injury [ Time Frame: 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).


Original Primary Outcome: Same as current

Current Secondary Outcome: relative reduction in estimated glomerular filtration rate [ Time Frame: 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.


Original Secondary Outcome: Same as current

Information By: Beijing Anzhen Hospital

Dates:
Date Received: March 31, 2013
Date Started: March 2012
Date Completion: June 2013
Last Updated: April 9, 2013
Last Verified: April 2013