A Safety Comparison of Iopromide and Iodixanol in Renal Impaired Patients

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

PHASE4

Total Enrollment

592 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2011-05-31

Brief Summary

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The investigators intend to find out which contrast agent has less kidney toxicity in renal impaired patients undergoing cardiac angiography or percutaneous coronary intervention (PCI).

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Detailed Description

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In the diagnosis and treatment of coronary heart disease, patients should undergo cardiac angiography or percutaneous coronary intervention (PCI). In those procedures, the investigators should use the contrast media, and it may cause kidney toxicity especially in the patients with chronic renal insufficiency.

Conditions

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Kidney Failure, Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Iopromide

Drug: Ultravist 370 mgl/ml, injection of intra-artery during cardiac interventional operation

Group Type EXPERIMENTAL

Iopromide (Ultravist)

Intervention Type DRUG

Iopromide (contrast agent), 370 mgl/ml, an nonionic, monomeric, LOCM

Iodixanol

Drug: Visipaque 320 mgl/ml, injection of intra-artery

Group Type ACTIVE_COMPARATOR

Iodixanol (Visipaque)

Intervention Type DRUG

Iodixanol (contrast agent) 320 mgl/ml, a nonionic, dimeric, IOCM

Interventions

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Iopromide (Ultravist)

Iopromide (contrast agent), 370 mgl/ml, an nonionic, monomeric, LOCM

Intervention Type DRUG

Iodixanol (Visipaque)

Iodixanol (contrast agent) 320 mgl/ml, a nonionic, dimeric, IOCM

Intervention Type DRUG

Other Intervention Names

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Ultravist Visipaque

Eligibility Criteria

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Inclusion Criteria

* 18 years old or older
* Plan to undergo Cardiac Catheterization
* Signed ICF
* eGFR: 30\~59 mL/min/1.73m2

Exclusion Criteria

* Pregnancy
* Under dialysis
* Conditions interfering with Cardiac Catheterization
* Participation in other trials
* Allergic to X-ray contrast media
* Administration of any investigational drug within the previous 30 days
* Intra-arterial or intravenous administration of iodinated contrast medium from 7 days before to 72 hours after the administration of study drug
* Left ventricular ejection fraction (LVEF) less than 30% by ultrasound examination
* Intake of any nephrotoxic medications 24 hours before or after the administration of study drug

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Chinese PLA general hospital

Principal Investigators

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Yundai Chen, MD

Role: PRINCIPAL_INVESTIGATOR

Chinese PLA General Hospital

Locations

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