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Completed

NCT Number: NCT02195726

Efficacy of RIPC to Reduce AKI for Patients Undergoing PCI

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Institut Cardiovasculaire Paris Sud Hôpital Jacques Cartier, Paris, France

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Remote ischemic preconditioning

Procedure

four times 5-minute inflations of a blood pressure cuff to 200 mmHg around the upper non dominant arm (or if systolic pressure is more than 150 mmHg, inflation will reach 50 mmHg up per than baseline), followed by 5-minute intervals of reperfusion.

Sham remote ischemic preconditioning

Procedure

In the control group sham preconditioning will be performed with inflation of 10 mmHg more than baseline.

Primary outcomes

  1. 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

  1. Incidence of periprocedural myocardial infarction

    Time frame: 24 and 48 hours after PCI

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Acronym: EUROCRIPS

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 21, 2014
Registry last updated
Jul 21, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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