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A Study of Two Iodinated Contrast Agents in Renally Impaired Patients Undergoing Cardiac Angiography

NCT ID: NCT00289029

Last Updated: 2006-08-18

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

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2006-06-30

Brief Summary

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The main purpose of this study is to compare the incidence of contrast induced nephrotoxicity following the administration of Isovue or Visipaque in patients with moderate to severe renal insufficiency undergoing cardiac angiography. Serum creatinine will be measured before and up to 48-72 hours after the administration of the contrast agent to evaluate renal function.

Detailed Description

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Conditions

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CIN

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Interventions

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Iopamidol 370 mgI/mL

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Referred for cardiac angiography; with a documented predose eGFR of greater than or equal to 20 and less than 60 mL/min/1.73m2

Exclusion Criteria

* Unstable renal function; concurrent administration of nephrotoxic drugs, undergoing dialysis
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bracco Diagnostics, Inc

INDUSTRY

Sponsor Role lead

Principal Investigators

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Marie Morris

Role: STUDY_DIRECTOR

Bracco Diagnostics, Inc

Locations

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Bracco Diagnostics, Inc

Princeton, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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IOP104

Identifier Type: -

Identifier Source: org_study_id