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
About this trial
This is an interventional prevention trial for Renal Insufficiency
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
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
NCT ID
NCT02463604
First Posted
June 2, 2015
Last Updated
June 21, 2018
Sponsor
University Hospital, Angers
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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