Kidney Damage in Patients With Normal eGFR

Bracco Diagnostics, Inc49 enrolled

Overview

This is a pilot study, randomized, double-blind, parallel group comparison of two iodinated contrast agents used during percutaneous coronary intervention (PCI). All patients enrolled must have normal eGFR. Statistical summaries will be presented to analyse the various laboratory tests for the two groups.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

TRIPLE

Enrollment

Conditions

Coronary Artery Stenosis

Interventions

Non ionic contrast media comparatorDRUG

One time administration for PCI

Non ionic contrast media comparatorDRUG

one time administration for PCI

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Provides written Informed Consent and is willing to comply with protocol requirements; * Is at least 18 years of age; * Is scheduled to undergo a percutaneous coronary intervention and/or diagnostic coronary angiography. * Has documented estimated glomerular filtration rate \[eGFR\] ≥60 mL/min/1.73 m2 calculated with the MDRD formula within 72 hours prior to enrollment. Exclusion Criteria: * Is a pregnant or lactating female. * Has a history of severe congestive heart failure * Has a history of hyperthyroidism * Has a history of hypersensitivity to iodinated contrast agents * Has unstable renal function

Locations (1)

Prairie Cardiovascular Consultants, Ltd.

Springfield, Illinois, United States

Outcomes

Primary Outcomes

Impact on the Trajectory of Serum and Urinary NGAL Following the Administration of Non-ionic Low Osmolar Contrast Media.

Mean change from baseline values for serum NGAL at 2,4,6,24,48 and 72 hours, and urine NGAL at 2,4,6,24, and 48 hours following the administration of non-ionic low osmolar contrast media.

Time frame: Baseline and 2, 4, 6, 24, 48, and 72 hours post-dose

Data from ClinicalTrials.gov

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