Skip to main content
OpenTrials
Completed

NCT Number: NCT02463604

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Renal Insufficiency Contrast Medium-induced Renal Insufficiency Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UH Angers - Cardiology ward

Angers, 49000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Coronary Angiography

Procedure

Coronary angiography is performed following usual site standards

Primary outcomes

  1. 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

  1. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Registry information

Acronym: PREPARE

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Jun 4, 2015
Registry last updated
Jun 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.