Skip to main content
OpenTrials
Completed

NCT Number: NCT01137786

Kidney Damage in Patients With Normal eGFR

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Coronary Artery Stenosis Cardiovascular Diseases Coronary Disease Coronary Stenosis Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Prairie Cardiovascular Consultants, Ltd.

Springfield, Illinois, 62701, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non ionic contrast media comparator

Drug

One time administration for PCI

Other names: Isovue 370

Primary outcomes

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

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

    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.

Sponsors and collaborators

Lead sponsor

Bracco Diagnostics, Inc

Industry

Registry information

Official study title

A Phase IV Pilot Study to Evaluate Kidney Damage Measured by Neutrophil Gelatinase-Associated Lipocalin (NGAL) as a New Bio-Marker in Patients With Normal eGFR Undergoing Percutaneous Coronary Intervention With IOPAMIDOL Injection 370 or IODIXANOL 320

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jun 4, 2010
Registry last updated
Sep 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.