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

Not Applicable

Completed

• Conditions: Contrast Medium-induced Renal Insufficiency; Renal Insufficiency
• Interventions: Procedure: Coronary Angiography

• Registration Number: NCT02463604
• Lead Sponsor: University Hospital, Angers

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.

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-06-02
• Study First Submitted QC: 2015-06-03
• Study First Posted: 2015-06-04
• Primary Completion: 2016-02
• Study Completion: 2017-03-24
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-21
• Last Update Posted: 2018-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Coronary Angiography	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.
Remote Ischemic Preconditioning	Coronary Angiography	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.

Primary Outcome Measures

Name	Time	Method
Increase in serum creatinin level (≥25% or 0,5mg/dL)	48h after coronary angiography	Serum creatinin level is measured 48h after coronary angiography to assess contrast medium-induced nephropathy

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

UH Angers - Cardiology ward; 🇫🇷 Angers, France