Coronary Artery Stenosis Clinical Trial
Official title:
Pilot Study to Evaluate Kidney Damage Measured by Neutrophil Gelatinase-Associated Lipocalin as New Biomarker in Patients With Moderate Fall in eGFR Undergoing Percutaneous Coronary Intervention With IOPAMIDOL Injection 370 or IODIXANOL 320
NCT number | NCT01136876 |
Other study ID # | IOP-117 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | November 2010 |
Est. completion date | November 2012 |
Verified date | September 2013 |
Source | Bracco Diagnostics, Inc |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To compare Iopamidol injection 370 and Iodixanol 320 in evaluating Neutrophil Gelatinase-Associated Lipocalin (NGAL) in patients with moderate fall in eGFR
Status | Completed |
Enrollment | 57 |
Est. completion date | November 2012 |
Est. primary completion date | November 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Canada | Montreal Heart Institute | Montréal | Quebec |
United States | UMDNJ - RWJ Medical School | New Brunswick | New Jersey |
United States | Research Cooperative, St. John's Hospital | Springfield | Illinois |
United States | The Institute for Clinical Research at Holy Name Medical Center | Teaneck | New Jersey |
Lead Sponsor | Collaborator |
---|---|
Bracco Diagnostics, Inc |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Impact on the Trajectory of Serum and Urinary Neutrophil Gelatinase-associated Lipocalin (NGAL) Following Administration | 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. | Baseline and 2, 4, 6, 24, 48,and 72 hours post-dose |
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