Back to resultsKidney Damage in Patients With Moderate Fall in eGFR
Primary Purpose
Coronary Artery Stenosis
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Iopamidol
Iodixanol-320
Sponsored by
About this trial
This is an interventional diagnostic trial for Coronary Artery Stenosis
Eligibility Criteria
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
Sites / Locations
- Research Cooperative, St. John's Hospital
- UMDNJ - RWJ Medical School
- The Institute for Clinical Research at Holy Name Medical Center
- Montreal Heart Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Iopamidol
Iodixanol
Arm Description
Non-ionic low-osmolar iodinated contrast media
Non-ionic iso-osmolar iodinated contrast media comparator
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01136876
Brief Title
Kidney Damage in Patients With Moderate Fall in eGFR
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bracco Diagnostics, Inc
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Stenosis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
57 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Iopamidol
Arm Type
Active Comparator
Arm Description
Non-ionic low-osmolar iodinated contrast media
Arm Title
Iodixanol
Arm Type
Active Comparator
Arm Description
Non-ionic iso-osmolar iodinated contrast media comparator
Intervention Type
Drug
Intervention Name(s)
Iopamidol
Other Intervention Name(s)
Isovue-370
Intervention Description
Iopamidol 370, one time administration for percutaneous coronary intervention
Intervention Type
Drug
Intervention Name(s)
Iodixanol-320
Other Intervention Name(s)
Visipaque 320
Intervention Description
Iodixanol-320 single administration for percutaneous coronary intervention procedure
Primary Outcome Measure Information:
Title
Impact on the Trajectory of Serum and Urinary Neutrophil Gelatinase-associated Lipocalin (NGAL) Following Administration
Description
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.
Time Frame
Baseline and 2, 4, 6, 24, 48,and 72 hours post-dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Luigia Storto, MD
Organizational Affiliation
Bracco Diagnostics, Inc
Official's Role
Study Director
Facility Information:
Facility Name
Research Cooperative, St. John's Hospital
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62701
Country
United States
Facility Name
UMDNJ - RWJ Medical School
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
The Institute for Clinical Research at Holy Name Medical Center
City
Teaneck
State/Province
New Jersey
ZIP/Postal Code
07666
Country
United States
Facility Name
Montreal Heart Institute
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H1T 1C8
Country
Canada
12. IPD Sharing Statement
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Kidney Damage in Patients With Moderate Fall in eGFR
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