NCT00289029

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2005

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 7, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 9, 2006

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

August 18, 2006

Status Verified

August 1, 2006

First QC Date

February 7, 2006

Last Update Submit

August 17, 2006

Conditions

CIN

Outcome Measures

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

Interventions

Iopamidol 370 mgI/mLDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Unstable renal function; concurrent administration of nephrotoxic drugs, undergoing dialysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bracco Diagnostics, Inc

Princeton, New Jersey, United States

Location

Study Officials

  • Marie Morris

    Bracco Diagnostics, Inc

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 7, 2006

First Posted

February 9, 2006

Study Start

July 1, 2005

Study Completion

June 1, 2006

Last Updated

August 18, 2006

Record last verified: 2006-08

Locations

US(1)