A Study of Two Iodinated Contrast Agents in Renally Impaired Patients Undergoing Cardiac Angiography
Sponsor
Bracco Diagnostics, Inc (Industry)
Overall Status
Completed
CT.gov ID
NCT00289029
Collaborator
(none)
400
1
11
36.3
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Official Title:
Visipaque and Isovue in Cardiac Angiography in Renally Impaired Patients
Study Start Date
:
Jul 1, 2005
Study Completion Date
:
Jun 1, 2006
Outcome Measures
Primary Outcome Measures
- Increase in SCr at 48-72 hours post dose []
Secondary Outcome Measures
- Decrease in eGFR at 48-72 hours post dose; occurrence of adverse events; effect on heart rate []
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Bracco Diagnostics, Inc | Princeton | New Jersey | United States |
Sponsors and Collaborators
- Bracco Diagnostics, Inc
Investigators
- Study Director: Marie Morris, Bracco Diagnostics, Inc
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00289029
Other Study ID Numbers:
- IOP104
First Posted:
Feb 9, 2006
Last Update Posted:
Aug 18, 2006
Last Verified:
Aug 1, 2006