NCT02195726

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,110

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2013

Geographic Reach
3 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

January 14, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 21, 2014

Completed
Last Updated

July 21, 2014

Status Verified

July 1, 2014

Enrollment Period

1.5 years

First QC Date

January 14, 2013

Last Update Submit

July 18, 2014

Conditions

Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

  • 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

    24 and 48 hours after PCI

Secondary Outcomes (1)

  • Incidence of periprocedural myocardial infarction

    24 and 48 hours after PCI

Study Arms (2)

Sham remote ischemic preconditioning'

SHAM COMPARATOR

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

Procedure: Sham remote ischemic preconditioning

Remote ischemic preconditioning

EXPERIMENTAL

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

Procedure: Remote ischemic preconditioning

Interventions

Remote ischemic preconditioningPROCEDURE

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.

Remote ischemic preconditioning
Sham remote ischemic preconditioningPROCEDURE

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

Sham remote ischemic preconditioning'

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Institut Cardiovasculaire Paris Sud Hôpital Jacques Cartier

Paris, France

Location

Unità Operativa di Cardiologia Presidio Ospedaliero Misericordia Via Senese 161 58100 Grosseto

Grosseto, Italy

Location

Azienda Ospedaliere Senese Siena

Siena, Italy

Location

Ospedale Maria Vittoria

Turin, 10016, Italy

Location

San Luigi

Turin, 10016, Italy

Location

Città Della Salute e Della Scienza

Turin, Italy

Location

Hospital Clínico San Carlos

Madrid, Spain

Location

Related Publications (2)

  • 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.

    PMID: 34111564DERIVED

  • 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.

    PMID: 29506674DERIVED

Related Links

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dottor, Head of the Catch Lab

Study Record Dates

First Submitted

January 14, 2013

First Posted

July 21, 2014

Study Start

January 1, 2013

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

July 21, 2014

Record last verified: 2014-07

Locations

ES(1)IT(5)FR(1)