Kidney Damage in Patients With Normal eGFR

Completed · Phase 4

Conditions studied: Coronary Artery Stenosis

In brief

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.

Key facts

Study ID

NCT01137786

Run by

Bracco Diagnostics, Inc

People needed

49

Starts

2010-12-01

Expected to finish

2012-04-01

Last updated by the study team

2013-09-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Prairie Cardiovascular Consultants, Ltd. — Springfield, Illinois, United States

Full record on ClinicalTrials.gov

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