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

Bracco Diagnostics, Inc400 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

DOUBLE

Enrollment

400

Conditions

CIN

Interventions

Iopamidol 370 mgI/mLDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Bracco Diagnostics, Inc

Princeton, New Jersey, United States

Outcomes

Primary Outcomes

Increase in SCr at 48-72 hours post dose

Secondary Outcomes

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

Data from ClinicalTrials.gov

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