Renal Effects of Three Iodinated Contrast Media (CM) in Patients at Risk Undergoing Coronary Angiography

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

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Brief Summary

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The study is to evaluate and compare the effects on kidney function of three iodinated contrast media (CM) in patients at risk of kidney damage evaluating serum creatinine (Scr) concentrations up to three days after CM administration.

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Detailed Description

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Conditions

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Coronary Artery Disease (CAD) Renal Impairment Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Interventions

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Iodixanol, Ioversol, Iopromide

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects with a combination of DM (type I or II) and renal impairment (RI), defined as SCr ≥150 µmol/L (1.7 mg/dL) for men and ≥133 µmol/L (1.5 mg/dL) for women or creatinine clearance (CrCl) ≤50 mL/min calculated according to Cockroft-Gault formula, referred for coronary angiography with or without PCI.

Exclusion Criteria

* Concurrent administration of potentially nephroprotective or nephrotoxic drugs is not allowed. Subjects undergoing dialysis or kidney transplantation or with CrCl \< 20 mL/min will not be included.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No