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Efficacy of RIPC to Reduce AKI for Patients Undergoing PCI (EUROCRIPS)

Primary Purpose

Acute Kidney Injury

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Remote ischemic preconditioning
Sham remote ischemic preconditioning
Sponsored by
Azienda Ospedaliera Città della Salute e della Scienza di Torino
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Kidney Injury

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

  • Institut Cardiovasculaire Paris Sud Hôpital Jacques Cartier
  • Unità Operativa di Cardiologia Presidio Ospedaliero Misericordia Via Senese 161 58100 Grosseto
  • Azienda Ospedaliere Senese Siena
  • Ospedale Maria Vittoria
  • San Luigi
  • Città Della Salute e Della Scienza
  • Hospital Clínico San Carlos

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Sham remote ischemic preconditioning'

Remote ischemic preconditioning

Arm Description

In the control group Sham remote ischemic preconditioning will be performed with inflation of 10 mmHg more than baseline

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

Outcomes

Primary Outcome Measures

Incidence of acute kidney injury
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

Incidence of periprocedural myocardial infarction

Full Information

First Posted
January 14, 2013
Last Updated
July 18, 2014
Sponsor
Azienda Ospedaliera Città della Salute e della Scienza di Torino
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1. Study Identification

Unique Protocol Identification Number
NCT02195726
Brief Title
Efficacy of RIPC to Reduce AKI for Patients Undergoing PCI
Acronym
EUROCRIPS
Official Title
The EUROpean and Asian Cardiac and Renal Remote Ischemic Pre-conditioning Study : A Prospective, Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Ospedaliera Città della Salute e della Scienza di Torino

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
1110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sham remote ischemic preconditioning'
Arm Type
Sham Comparator
Arm Description
In the control group Sham remote ischemic preconditioning will be performed with inflation of 10 mmHg more than baseline
Arm Title
Remote ischemic preconditioning
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Remote ischemic preconditioning
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Sham remote ischemic preconditioning
Intervention Description
In the control group sham preconditioning will be performed with inflation of 10 mmHg more than baseline.
Primary Outcome Measure Information:
Title
Incidence of acute kidney injury
Description
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
Time Frame
24 and 48 hours after PCI
Secondary Outcome Measure Information:
Title
Incidence of periprocedural myocardial infarction
Time Frame
24 and 48 hours after PCI

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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;
Facility Information:
Facility Name
Institut Cardiovasculaire Paris Sud Hôpital Jacques Cartier
City
Paris
Country
France
Facility Name
Unità Operativa di Cardiologia Presidio Ospedaliero Misericordia Via Senese 161 58100 Grosseto
City
Grosseto
Country
Italy
Facility Name
Azienda Ospedaliere Senese Siena
City
Siena
Country
Italy
Facility Name
Ospedale Maria Vittoria
City
Turin
ZIP/Postal Code
10016
Country
Italy
Facility Name
San Luigi
City
Turin
ZIP/Postal Code
10016
Country
Italy
Facility Name
Città Della Salute e Della Scienza
City
Turin
Country
Italy
Facility Name
Hospital Clínico San Carlos
City
Madrid
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
34111564
Citation
D'Ascenzo F, Femmino S, Ravera F, Angelini F, Caccioppo A, Franchin L, Grosso A, Comita S, Cavallari C, Penna C, De Ferrari GM, Camussi G, Pagliaro P, Brizzi MF. Extracellular vesicles from patients with Acute Coronary Syndrome impact on ischemia-reperfusion injury. Pharmacol Res. 2021 Aug;170:105715. doi: 10.1016/j.phrs.2021.105715. Epub 2021 Jun 7.
Results Reference
derived
PubMed Identifier
29506674
Citation
Moretti C, Cerrato E, Cavallero E, Lin S, Rossi ML, Picchi A, Sanguineti F, Ugo F, Palazzuoli A, Bertaina M, Presbitero P, Shao-Liang C, Pozzi R, Giammaria M, Limbruno U, Lefevre T, Gasparetto V, Garbo R, Omede P, Sheiban I, Escaned J, Biondi-Zoccai G, Gaita F, Perl L, D'Ascenzo F. The EUROpean and Chinese cardiac and renal Remote Ischemic Preconditioning Study (EURO-CRIPS CardioGroup I): A randomized controlled trial. Int J Cardiol. 2018 Apr 15;257:1-6. doi: 10.1016/j.ijcard.2017.12.033.
Results Reference
derived
Links:
URL
http://www.cardiogroup.org/index.php?cat=home
Description
our research website group

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Efficacy of RIPC to Reduce AKI for Patients Undergoing PCI

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