Phase 4 N=49 Randomized Triple-blind Diagnostic

Kidney Damage in Patients With Normal eGFR

Coronary Artery Stenosis

Bottom Line

View on ClinicalTrials.gov: NCT01137786 ↗

Enrolled (actual)

Serious AEs

2.0%

Results posted

Sep 2013

Primary outcome: Primary: Impact on the Trajectory of Serum and Urinary NGAL Following the Administration of Non-ionic Low Osmolar Contrast Media. — -14.84; -17.71; -9.98; -2.37 ng/mL

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Non ionic contrast media comparator (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Bracco Diagnostics, Inc
Primary completion: Apr 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Impact on the Trajectory of Serum and Urinary NGAL Following the Administration of Non-ionic Low Osmolar Contrast Media.	-14.84; -17.71; -9.98; -2.37; -12.86; -29.33	—

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 eGFR. Statistical summaries will be presented to analyse the various laboratory tests for the two groups.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01137786). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.