Efficacy of RIPC to Reduce AKI for Patients Undergoing PCI

Phase 4

Completed

• Conditions: Acute Kidney Injury
• Interventions: Procedure: Remote ischemic preconditioning; Procedure: Sham remote ischemic preconditioning

• Registration Number: NCT02195726
• Lead Sponsor: A.O.U. Città della Salute e della Scienza

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

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-14
• Status Verified: 2014-07
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Study First Submitted QC: 2014-07-18
• Last Update Submitted: 2014-07-18
• Study First Posted: 2014-07-21
• Last Update Posted: 2014-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1110

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Remote ischemic preconditioning	Remote ischemic preconditioning	In the experimental group, patients will receive for 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 upper than baseline), followed by 5-minute intervals of reperfusion. In subjects presenting with BMI \> 30 a dedicated blood pressure cuff for obese patients will be used. Coronary angiography will be performed in 45 minutes from last inflation
Sham remote ischemic preconditioning'	Sham remote ischemic preconditioning	In the control group Sham remote ischemic preconditioning will be performed with inflation of 10 mmHg more than baseline

Primary Outcome Measures

Name	Time	Method
Incidence of acute kidney injury	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 Outcome Measures

Name	Time	Method
Incidence of periprocedural myocardial infarction	24 and 48 hours after PCI

Trial Locations

Locations (7)

Unità Operativa di Cardiologia Presidio Ospedaliero Misericordia Via Senese 161 58100 Grosseto; 🇮🇹 Grosseto, Italy

Hospital Clínico San Carlos; 🇪🇸 Madrid, Spain

Ospedale Maria Vittoria; 🇮🇹 Turin, Italy

Institut Cardiovasculaire Paris Sud Hôpital Jacques Cartier; 🇫🇷 Paris, France

San Luigi; 🇮🇹 Turin, Italy

Azienda Ospedaliere Senese Siena; 🇮🇹 Siena, Italy

Città Della Salute e Della Scienza; 🇮🇹 Turin, Italy