Status:
COMPLETED
Kidney Damage in Patients With Moderate Fall in eGFR
Lead Sponsor:
Bracco Diagnostics, Inc
Conditions:
Coronary Artery Stenosis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
To compare Iopamidol injection 370 and Iodixanol 320 in evaluating Neutrophil Gelatinase-Associated Lipocalin (NGAL) in patients with moderate fall in eGFR
Detailed Description
This is a pilot study having a randomized, double-blind parallel group comparison of two iodinated contrast agents used during percutaneous coronary intervention (PCI). All patients enrolled must have...
Eligibility Criteria
Inclusion
- At least 18 years of age and provides informed consent
- Scheduled to undergo percutaneous coronary intervention
- Documented pre-dose Estimated glomerular filtration rate (eGFR) of greater than or equal to 30 mL/min/1.73 m squared and less than or equal to 59 mL/min/1.73 m squared
Exclusion
- Pregnant or lactating females
- Severe congestive heart failure
- History of hyperthyroidism;
- Unstable renal function
- Emergency PCI
- History of hypersensitivity to iodinated contrast agents
- Receiving diuretics to prevent acute renal injury
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT01136876
Start Date
November 1 2010
End Date
November 1 2012
Last Update
November 4 2020
Active Locations (4)
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1
Research Cooperative, St. John's Hospital
Springfield, Illinois, United States, 62701
2
UMDNJ - RWJ Medical School
New Brunswick, New Jersey, United States, 08901
3
The Institute for Clinical Research at Holy Name Medical Center
Teaneck, New Jersey, United States, 07666
4
Montreal Heart Institute
Montreal, Quebec, Canada, H1T 1C8