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

CIN Clinical Trial

Official title:

Visipaque and Isovue in Cardiac Angiography in Renally Impaired Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00289029
• Other study ID #: IOP104
• Status: Completed
• Phase: Phase 4
• First received: February 7, 2006
• Last updated: August 17, 2006
• Start date: July 2005
• Est. completion date: June 2006

Study information

• Verified date: August 2006
• Source: Bracco Diagnostics, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind

Related Conditions & MeSH terms

• CIN

Intervention

Drug:
• Iopamidol 370 mgI/mL

Locations

Country	Name	City	State
United States	Bracco Diagnostics, Inc	Princeton	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Bracco Diagnostics, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increase in SCr at 48-72 hours post dose
Secondary	Decrease in eGFR at 48-72 hours post dose; occurrence of adverse events; effect on heart rate