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

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.

Study Overview

• Status: Completed
• Conditions: Renal Insufficiency; Contrast Medium-induced Renal Insufficiency
• Intervention / Treatment: Procedure: Coronary Angiography

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.

• Study Type: Interventional
• Enrollment (Actual): 220
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Angers, France, 49000
    • UH Angers - Cardiology ward

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Remote Ischemic Preconditioning; 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.	Procedure: Coronary Angiography; Coronary angiography is performed following usual site standards
Sham Comparator: Control; 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.	Procedure: Coronary Angiography; Coronary angiography is performed following usual site standards

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	48h after coronary angiography

Secondary Outcome Measures

Outcome Measure	Time Frame
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	12 months after coronary angiography

Collaborators and Investigators

• Sponsor: University Hospital, Angers
• Investigators: Principal Investigator: Fabrice Prunier, Professor, UH Angers, Cardiology

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): March 24, 2017

Study Registration Dates

• First Submitted: June 2, 2015
• First Submitted That Met QC Criteria: June 3, 2015
• First Posted (Estimate): June 4, 2015

Study Record Updates

• Last Update Posted (Actual): June 25, 2018
• Last Update Submitted That Met QC Criteria: June 21, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency
• Other Study ID Numbers: 2014-A01281-46