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

June 21, 2018 updated by: University Hospital, Angers
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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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)
Time Frame: 48h after coronary angiography
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
Time Frame: 12 months after coronary angiography
12 months after coronary angiography

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Angers

Investigators

  • Principal Investigator: Fabrice Prunier, Professor, UH Angers, Cardiology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Other Study ID Numbers

  • 2014-A01281-46

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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