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Completed

NCT Number: NCT00289029

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

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.

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Key information

Conditions

CIN

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Bracco Diagnostics, Inc

Princeton, New Jersey, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Iopamidol 370 mgI/mL

Drug

Primary outcomes

  1. Increase in SCr at 48-72 hours post dose

Secondary outcomes

  1. Decrease in eGFR at 48-72 hours post dose; occurrence of adverse events; effect on heart rate

Sponsors and collaborators

Lead sponsor

Bracco Diagnostics, Inc

Industry

Registry information

Official study title

Visipaque and Isovue in Cardiac Angiography in Renally Impaired Patients

Important dates

Study start
2005
Study completion
2006
First posted
Feb 9, 2006
Registry last updated
Aug 18, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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