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

University Hospital, Angers220 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

220

Conditions

Renal Insufficiency Contrast Medium-induced Renal Insufficiency

Interventions

Coronary AngiographyPROCEDURE

Coronary angiography is performed following usual site standards

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (1)

UH Angers - Cardiology ward

Angers, France

Outcomes

Primary Outcomes

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

Time frame: 48h after coronary angiography

Secondary Outcomes

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

Data from ClinicalTrials.gov

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