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

Sponsor

Meir Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT02468401

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Kidney Disease, Chronic Ischemic Heart Disease	Procedure: Percutaneous coronary intervention	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

The Efficacy of a New Protocol for Preventing Contrast Induced Nephropathy in Patients With Advanced Renal Dysfunction Undergoing Coronary Interventions

Study Start Date :

Sep 1, 2015

Actual Primary Completion Date :

Aug 1, 2016

Actual Study Completion Date :

Aug 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Coronary angiography Patients undergoing coronary angio with or without percutaneous coronary intervention using a new protocol designed to minimize the exposure to contrast medium	Procedure: Percutaneous coronary intervention Patients planned for coronary angiography or percutaneous coronary intervention will be managed using a protocol that allows us to use minimal volumes of contrast dye

Arm

Intervention/Treatment

Experimental: Coronary angiography

Patients undergoing coronary angio with or without percutaneous coronary intervention using a new protocol designed to minimize the exposure to contrast medium

Procedure: Percutaneous coronary intervention

Patients planned for coronary angiography or percutaneous coronary intervention will be managed using a protocol that allows us to use minimal volumes of contrast dye

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

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

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