Prevention of Contrast Induced Nephropathy in Patients With Advanced Renal Dysfunction Undergoing Coronary Interventions

Not Applicable

Completed

• Conditions: Ischemic Heart Disease; Kidney Disease, Chronic
• Interventions: Procedure: Percutaneous coronary intervention

• Registration Number: NCT02468401
• Lead Sponsor: Meir Medical Center

Brief Summary

There is a pressing need to find effective strategies for the prevention of contrast induced nephropathy in patients with advanced renal dysfunction. The current study was designed to assess the efficacy of a new protocol for preventing contrast induced nephropathy in patients with advanced renal dysfunction undergoing coronary interventions

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2015-06-03
• Study First Submitted QC: 2015-06-07
• Study First Posted: 2015-06-10
• Study Start: 2015-09
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-19
• Last Update Posted: 2016-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Patients with estimated glomerular filtration rate<45ml/min undergoing coronary angiography due to one of the following indications in accordance with the 2014 guidelines:

1. Elective coronary angiography due to symptoms suggestive for angina with a positive non-invasive ischemia assessment of ≥10% of left ventricle.
2. Non ST-elevation acute coronary syndrome with a GRACE score>110

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Exclusion Criteria

• Patients on dialysis or those planned for dialysis in the next 3 months.
• Patients with ST-elevation myocardial infarction
• No symptoms or signs of heart failure
• Treatment with IV diuretics during the 48 hours prior to enrolment
• Patients with acute renal failure (Creatinine raise of at least 0.3mg/dl from )baseline
• Patients post coronary artery bypass surgery

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Coronary angiography	Percutaneous coronary intervention	Patients undergoing coronary angio with or without percutaneous coronary intervention using a new protocol designed to minimize the exposure to contrast medium

Primary Outcome Measures

Name	Time	Method
Changes in glomerular filtration rate following coronary angiography or intervention	24 and 48 hours post procedure	Significant changes are defined as a reduction ≥25% in glomerular filtration rate

Trial Locations

Locations (1)

Meir Medical Center; 🇮🇱 Kfar Saba, Israel