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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date September 2013
Source Bracco Diagnostics, Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To compare Iopamidol injection 370 and Iodixanol 320 in evaluating Neutrophil Gelatinase-Associated Lipocalin (NGAL) in patients with moderate fall in eGFR


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 eGFR greater than or equal to 30 mL/min and less than or equal to 59 mL/min. Statistical summaries will be presented to analyze the various lab tests results for the two groups.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Iopamidol
Iopamidol 370, one time administration for percutaneous coronary intervention
Iodixanol-320
Iodixanol-320 single administration for percutaneous coronary intervention procedure

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Bracco Diagnostics, Inc

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

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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