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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2017-03-24

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Renal Insufficiency Contrast Medium-induced Renal Insufficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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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.

Group Type EXPERIMENTAL

Coronary Angiography

Intervention Type PROCEDURE

Coronary angiography is performed following usual site standards

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.

Group Type SHAM_COMPARATOR

Coronary Angiography

Intervention Type PROCEDURE

Coronary angiography is performed following usual site standards

Interventions

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Coronary Angiography

Coronary angiography is performed following usual site standards

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No