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Clinical Trials/NCT02195726
NCT02195726
Completed
Phase 4

The EUROpean and Asian Cardiac and Renal Remote Ischemic Pre-conditioning Study : A Prospective, Randomized Control Trial

A.O.U. Città della Salute e della Scienza7 sites in 3 countries1,110 target enrollmentJanuary 2013

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Acute Kidney Injury
Sponsor
A.O.U. Città della Salute e della Scienza
Enrollment
1110
Locations
7
Primary Endpoint
Incidence of acute kidney injury
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

The purpose of the present study is to determine if remote ischemic preconditioning reduces incidence of acute kidney injury in patients with reduced kidney function undergoing Percutaneous Coronary Intervention.

Detailed Description

Acute kidney injury negatively impacts on prognosis after PCI, and only hydratation have shown to reduce this complication. Remote ischemic preconditioning has been demonstrated to reduce periprocedural MI, while impact on aki remains to be assessed

Registry
clinicaltrials.gov
Start Date
January 2013
End Date
July 2014
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
A.O.U. Città della Salute e della Scienza
Responsible Party
Principal Investigator
Principal Investigator

Claudio Moretti

Dottor, Head of the Catch Lab

A.O.U. Città della Salute e della Scienza

Eligibility Criteria

Inclusion Criteria

  • undergoing PCI with stenting for all clinical indications
  • carrying (with) a renal clearance less than 60 mL/min/1.73 m2 and more than 30 mL/min/1.73 m2 (evaluated through MDRD); ù
  • younger than 85 years old.

Exclusion Criteria

  • ST Segment Elevation Myocardial Infarction (STEMI), unstable hemodynamic presentations (cardiogenic shock) or ongoing severe arrhythmias;

Outcomes

Primary Outcomes

Incidence of acute kidney injury

Time Frame: 24 and 48 hours after PCI

Acute Kidney Injury defined as Acute kidney injury is defined as an increase serum creatinine greater than 0.5 mg/dL, or by a relative increase of at least 25% over the baseline value within a period of 48-hours after contrast medium administration

Secondary Outcomes

  • Incidence of periprocedural myocardial infarction(24 and 48 hours after PCI)

Study Sites (7)

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