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Completed

NCT Number: NCT01136876

Kidney Damage in Patients With Moderate Fall in eGFR

To compare Iopamidol injection 370 and Iodixanol 320 in evaluating Neutrophil Gelatinase-Associated Lipocalin (NGAL) in patients with moderate fall in eGFR

Completed

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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

Montreal Heart Institute, Montreal, Quebec, Canada

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About this study

This is a pilot study having a randomized, double-blind parallel group comparison of two iodinated contrast agents used during percutaneous coronary intervention (PCI). All patients enrolled must have eGFR greater than or equal to 30 mL/min and less than or equal to 59 mL/min. Statistical summaries will be presented to analyze the various lab tests results for the two groups.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • At least 18 years of age and provides informed consent
  • Scheduled to undergo percutaneous coronary intervention
  • Documented pre-dose Estimated glomerular filtration rate (eGFR) of greater than or equal to 30 mL/min/1.73 m squared and less than or equal to 59 mL/min/1.73 m squared

Exclusion criteria

  • Pregnant or lactating females
  • Severe congestive heart failure
  • History of hyperthyroidism;
  • Unstable renal function
  • Emergency PCI
  • History of hypersensitivity to iodinated contrast agents
  • Receiving diuretics to prevent acute renal injury

Treatment and study plan

Iopamidol

Drug

Iopamidol 370, one time administration for percutaneous coronary intervention

Other names: Isovue-370

Iodixanol-320

Drug

Iodixanol-320 single administration for percutaneous coronary intervention procedure

Other names: Visipaque 320

Primary outcomes

  1. Impact on the Trajectory of Serum and Urinary Neutrophil Gelatinase-associated Lipocalin (NGAL) Following Administration

    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 contrast media.

Sponsors and collaborators

Lead sponsor

Bracco Diagnostics, Inc

Industry

Registry information

Official study title

Pilot Study to Evaluate Kidney Damage Measured by Neutrophil Gelatinase-Associated Lipocalin as New Biomarker in Patients With Moderate Fall in 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
Nov 4, 2020

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.

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