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Clinical Trials/NCT01827891
NCT01827891
Unknown
Not Applicable

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

Beijing Anzhen Hospital1 site in 1 country310 target enrollmentMarch 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Kidney Injury
Sponsor
Beijing Anzhen Hospital
Enrollment
310
Locations
1
Primary Endpoint
acute kidney injury
Last Updated
13 years ago

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.

Registry
clinicaltrials.gov
Start Date
March 2012
End Date
June 2013
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Beijing Anzhen Hospital
Responsible Party
Principal Investigator
Principal Investigator

Yujie Zhou

professor of cardiology, Vice president of Beijing Anzhen Hospital

Beijing Anzhen Hospital

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.

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)

Study Sites (1)

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