Phase 4
Completed N=49
Kidney Damage in Patients With Normal eGFR
Source: ClinicalTrials.gov NCT01137786 ↗Enrolled (actual)
49
Serious AEs
2.0%
Results posted
Sep 2013
Primary outcomePrimary: 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
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.
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 | — |
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
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. Informational only — not medical advice.