Skip to main content
Clinical Trials/NCT01827891
NCT01827891UnknownNot Applicable

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

Beijing Anzhen Hospital2 sites in 1 country310 target enrollmentStarted: March 1, 2012Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
310
Locations
2
Primary Endpoint
acute kidney injury

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

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).

Secondary Outcomes

  • relative reduction in estimated glomerular filtration rate(180 days after procedure)

Investigators

Sponsor
Beijing Anzhen Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Yujie Zhou

professor of cardiology, Vice president of Beijing Anzhen Hospital

Beijing Anzhen Hospital

Study Sites (2)

Loading locations...

Similar Trials