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Clinical Trials/NCT02463604
NCT02463604
Completed
N/A

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

University Hospital, Angers1 site in 1 country220 target enrollmentJune 2015

Overview

Phase
N/A
Intervention
Not specified
Conditions
Renal Insufficiency
Sponsor
University Hospital, Angers
Enrollment
220
Locations
1
Primary Endpoint
Increase in serum creatinin level (≥25% or 0,5mg/dL)
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2015
End Date
March 24, 2017
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Hospital, Angers
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Increase in serum creatinin level (≥25% or 0,5mg/dL)

Time Frame: 48h after coronary angiography

Serum creatinin level is measured 48h after coronary angiography to assess contrast medium-induced nephropathy

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(12 months after coronary angiography)

Study Sites (1)

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