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

NCT ID: NCT02468401

Last Updated: 2016-11-22

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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2016-08-31

Brief Summary

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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

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Conditions

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Kidney Disease, Chronic Ischemic Heart Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Coronary angiography

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

Group Type EXPERIMENTAL

Percutaneous coronary intervention

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Meir Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Pereg David

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Meir Medical Center

Kfar Saba, Israel, Israel

Site Status

Countries

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Israel

References

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Rozenbaum Z, Benchetrit S, Rozenbaum E, Neumark E, Mosseri M, Pereg D. Ultra-Low Contrast Volume for Patients with Advanced Chronic Kidney Disease Undergoing Coronary Procedures. Nephron. 2018;138(4):296-302. doi: 10.1159/000485648. Epub 2018 Jan 24.

Reference Type DERIVED
PMID: 29393219 (View on PubMed)

Other Identifiers

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0103-15-MMC

Identifier Type: -

Identifier Source: org_study_id