Kidney Damage In Patients With Severe Fall In eGFR
Phase 4
Terminated
- Conditions
- Coronary Artery Stenosis
- Interventions
- Registration Number
- NCT01136915
- Lead Sponsor
- Bracco Diagnostics, Inc
- Brief Summary
This is a pilot study using a randomized, double blinded, comparison of two iodinated contrast agents used during percutaneous coronary intervention (PCI). All patients enrolled must have and estimated glomerular filtration \[eGFR\] \< 30 mL/min/1.73 m2. Statistical summaries will be presented to analyse the various laboratory tests for the two groups.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 15
Inclusion Criteria
- Provides written Informed Consent
- Is at least 18 years of age;
- Is scheduled for or likely to undergo percutaneous coronary intervention;
- Has documented estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73 m2 calculated with the MDRD formula within 72 hours prior the enrolment.
Exclusion Criteria
- Is a pregnant or lactating female
- Has a history of severe congestive heart failure
- Has a history of hyperthyroidism
- Has unstable renal function
- Has a history of hypersensitivity to iodinated contrast agents
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description IOPAMIDOL injection 370 Iopamidol 370 - Iodixanol 320 Iodixanol 320 -
- Primary Outcome Measures
Name Time Method Impact on the Trajectory of Serum and Urinary NGAL Following the Administration of Non-ionic, Low-osmolar Contrast Media in Comparison to a Non-ionic, Iso-osmolar Contrast Media. 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Institu De Cardiologie De Montreal
🇨🇦Montreal, Quebec, Canada