Status:

COMPLETED

Kidney Damage in Patients With Normal eGFR

Lead Sponsor:

Bracco Diagnostics, Inc

Conditions:

Coronary Artery Stenosis

Eligibility:

All Genders

18+ years

Phase:

PHASE4

Brief Summary

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...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

December 1 2010

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 1 2012

Estimated Enrollment :

49 Patients enrolled

Trial Details

Trial ID

NCT01137786

Start Date

December 1 2010

End Date

April 1 2012

Last Update

September 30 2013

Active Locations (1)

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Prairie Cardiovascular Consultants, Ltd.

Springfield, Illinois, United States, 62701