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

Visipaque and Isovue in Cardiac Angiography in Renally Impaired Patients

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00289029

Enrollment

400

Registered

2006-02-09

Start date

2005-07-31

Completion date

2006-06-30

Last updated

2006-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CIN

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.

Interventions

DRUGIopamidol 370 mgI/mL

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Increase in SCr at 48-72 hours post dose	—

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026