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Renal PRotection Against Contrast mEdium-induced nephroPathy in High Risk Patients undErgoing Coronary Angiography (PREPARE)

Primary Purpose

Renal Insufficiency, Contrast Medium-induced Renal Insufficiency

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Coronary Angiography
Sponsored by
University Hospital, Angers
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Renal Insufficiency

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patient headed to coronary angiography

  2. Glomerular filtration rate :

    • ≤ 40ml/min/1,73m² (MDRD equation)
    • or ≤ 60ml/min/1,73m² (MDRD equation) with 1 additional risk factor : age > 75 years, NYHA ≥ III/IV, diabetes mellitus
  3. Signed informed consent

Exclusion Criteria:

  1. Preoperative assessment / dilated cardiomyopathy assessment
  2. Acute ST-segment elevation myocardial infarction
  3. Cardiogenic shock requiring pressor amine or systolic blood pressure <80mmHg
  4. Resuscitation after cardiac arrest
  5. Intra-aortic balloon pump
  6. Contraindication for the repeted use of an upper-arm pressure cuff
  7. Extra-renal epuration
  8. No health insurance coverage
  9. Legal incapacity (patients under tutorship, curatorship or judicial protection)
  10. Patient enrolled in another interventional trial or being in a washout period
  11. Incapacity/impossibility to undergo 12-month follow-up
  12. Patient refusal

Sites / Locations

  • UH Angers - Cardiology ward

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Remote Ischemic Preconditioning

Control

Arm Description

A blood pressure cuff is placed on upper arm and inflated to 200 mmHg for 5 minutes and then deflated for 5 minutes. This cycle is repeated 3 times in total. The procedure has to be completed between 5 and 60 minutes prior coronary angiography.

A blood pressure cuff is placed on upper arm and inflated to 10 mmHg for 5 minutes and then deflated for 5 minutes. This cycle is repeated 3 times in total. The procedure has to be completed between 5 and 60 minutes prior coronary angiography.

Outcomes

Primary Outcome Measures

Increase in serum creatinin level (≥25% or 0,5mg/dL)
Serum creatinin level is measured 48h after coronary angiography to assess contrast medium-induced nephropathy

Secondary Outcome Measures

Serum creatinin level is measured 12 months after coronary angiography and major adverse events are collected to assess long-term effects of remote ischemic preconditioning on renal function

Full Information

First Posted
June 2, 2015
Last Updated
June 21, 2018
Sponsor
University Hospital, Angers
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1. Study Identification

Unique Protocol Identification Number
NCT02463604
Brief Title
Renal PRotection Against Contrast mEdium-induced nephroPathy in High Risk Patients undErgoing Coronary Angiography
Acronym
PREPARE
Official Title
Renal PRotection Against Contrast mEdium-induced nephroPathy in High Risk Patients undErgoing Coronary Angiography
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
March 24, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study evaluates the efficacy of remote ischemic preconditioning on preventing contrast medium-induced nephropathy in a population of high risk patients undergoing coronary angiography. Half of participants will receive a preconditioning procedure while the other half will receive a sham procedure.
Detailed Description
Contrast medium-induced nephropathy has a big impact on clinical outcomes in patients suffering from renal insufficiency who undergo percutaneous coronary interventions. Remote ischemic preconditioning is proved to protect myocardium in patients undergoing percutaneous coronary angiography. We will evaluate the effect of remote preconditioning on renal protection.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Insufficiency, Contrast Medium-induced Renal Insufficiency

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
220 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Remote Ischemic Preconditioning
Arm Type
Experimental
Arm Description
A blood pressure cuff is placed on upper arm and inflated to 200 mmHg for 5 minutes and then deflated for 5 minutes. This cycle is repeated 3 times in total. The procedure has to be completed between 5 and 60 minutes prior coronary angiography.
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
A blood pressure cuff is placed on upper arm and inflated to 10 mmHg for 5 minutes and then deflated for 5 minutes. This cycle is repeated 3 times in total. The procedure has to be completed between 5 and 60 minutes prior coronary angiography.
Intervention Type
Procedure
Intervention Name(s)
Coronary Angiography
Intervention Description
Coronary angiography is performed following usual site standards
Primary Outcome Measure Information:
Title
Increase in serum creatinin level (≥25% or 0,5mg/dL)
Description
Serum creatinin level is measured 48h after coronary angiography to assess contrast medium-induced nephropathy
Time Frame
48h after coronary angiography
Secondary Outcome Measure Information:
Title
Serum creatinin level is measured 12 months after coronary angiography and major adverse events are collected to assess long-term effects of remote ischemic preconditioning on renal function
Time Frame
12 months after coronary angiography

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient headed to coronary angiography Glomerular filtration rate : ≤ 40ml/min/1,73m² (MDRD equation) or ≤ 60ml/min/1,73m² (MDRD equation) with 1 additional risk factor : age > 75 years, NYHA ≥ III/IV, diabetes mellitus Signed informed consent Exclusion Criteria: Preoperative assessment / dilated cardiomyopathy assessment Acute ST-segment elevation myocardial infarction Cardiogenic shock requiring pressor amine or systolic blood pressure <80mmHg Resuscitation after cardiac arrest Intra-aortic balloon pump Contraindication for the repeted use of an upper-arm pressure cuff Extra-renal epuration No health insurance coverage Legal incapacity (patients under tutorship, curatorship or judicial protection) Patient enrolled in another interventional trial or being in a washout period Incapacity/impossibility to undergo 12-month follow-up Patient refusal
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabrice Prunier, Professor
Organizational Affiliation
UH Angers, Cardiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
UH Angers - Cardiology ward
City
Angers
ZIP/Postal Code
49000
Country
France

12. IPD Sharing Statement

Learn more about this trial

Renal PRotection Against Contrast mEdium-induced nephroPathy in High Risk Patients undErgoing Coronary Angiography

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