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

Phase 4

Completed

• Conditions: CIN

• Registration Number: NCT00289029
• Lead Sponsor: Bracco Diagnostics, Inc

Brief Summary

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

Not available

Study Timeline

• Study Start: 2005-07
• Study First Submitted: 2006-02-07
• Study First Submitted QC: 2006-02-07
• Study First Posted: 2006-02-09
• Study Completion: 2006-06
• Status Verified: 2006-08
• Last Update Submitted: 2006-08-17
• Last Update Posted: 2006-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Increase in SCr at 48-72 hours post dose

Secondary Outcome Measures

Name	Time	Method
Decrease in eGFR at 48-72 hours post dose; occurrence of adverse events; effect on heart rate

Trial Locations

Locations (1)

Bracco Diagnostics, Inc; 🇺🇸 Princeton, New Jersey, United States