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

NCT02463604 | Completed

• 1 other identifier: 2014-A01281-46
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Insufficiency; Contrast Medium-induced Renal Insufficiency

Outcome Measures

Primary Outcomes (1)

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

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

  48h after coronary angiography

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

  12 months after coronary angiography

Study Arms (2)

Remote Ischemic Preconditioning

EXPERIMENTAL

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

Control

SHAM COMPARATOR

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

Interventions

Coronary Angiography PROCEDURE

Coronary angiography is performed following usual site standards

Control; Remote Ischemic Preconditioning

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

UH Angers - Cardiology ward

Angers, 49000, France

Location

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Fabrice Prunier, Professor

  UH Angers, Cardiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2015
• First Posted: June 4, 2015
• Study Start: June 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: March 24, 2017
• Last Updated: June 25, 2018

Record last verified: 2018-06

Locations

FR (1)