Back to resultsKidney Damage in Patients With Normal eGFR
Primary Purpose
Coronary Artery Stenosis
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Non ionic contrast media comparator
Non ionic contrast media comparator
Sponsored by
About this trial
This is an interventional diagnostic trial for Coronary Artery Stenosis
Eligibility Criteria
Inclusion Criteria:
- Provides written Informed Consent and is willing to comply with protocol requirements;
- Is at least 18 years of age;
- Is scheduled to undergo a percutaneous coronary intervention and/or diagnostic coronary angiography.
- Has documented estimated glomerular filtration rate [eGFR] ≥60 mL/min/1.73 m2 calculated with the MDRD formula within 72 hours prior to enrollment.
Exclusion Criteria:
- Is a pregnant or lactating female.
- Has a history of severe congestive heart failure
- Has a history of hyperthyroidism
- Has a history of hypersensitivity to iodinated contrast agents
- Has unstable renal function
Sites / Locations
- Prairie Cardiovascular Consultants, Ltd.
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
IOPAMIDOL 370
IODIXANOL 320
Arm Description
Outcomes
Primary Outcome Measures
Impact on the Trajectory of Serum and Urinary NGAL Following the Administration of Non-ionic Low Osmolar Contrast Media.
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 non-ionic low osmolar contrast media.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01137786
Brief Title
Kidney Damage in Patients With Normal eGFR
Official Title
A Phase IV Pilot Study to Evaluate Kidney Damage Measured by Neutrophil Gelatinase-Associated Lipocalin (NGAL) as a New Bio-Marker in Patients With Normal eGFR Undergoing Percutaneous Coronary Intervention With IOPAMIDOL Injection 370 or IODIXANOL 320
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 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
This is a pilot study, randomized, double-blind, parallel group comparison of two iodinated contrast agents used during percutaneous coronary intervention (PCI). All patients enrolled must have normal eGFR. Statistical summaries will be presented to analyse the various laboratory tests 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
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IOPAMIDOL 370
Arm Type
Active Comparator
Arm Title
IODIXANOL 320
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Non ionic contrast media comparator
Other Intervention Name(s)
Isovue 370
Intervention Description
One time administration for PCI
Intervention Type
Drug
Intervention Name(s)
Non ionic contrast media comparator
Other Intervention Name(s)
Visipaque 320
Intervention Description
one time administration for PCI
Primary Outcome Measure Information:
Title
Impact on the Trajectory of Serum and Urinary NGAL Following the Administration of Non-ionic Low Osmolar Contrast Media.
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 non-ionic low osmolar 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:
Provides written Informed Consent and is willing to comply with protocol requirements;
Is at least 18 years of age;
Is scheduled to undergo a percutaneous coronary intervention and/or diagnostic coronary angiography.
Has documented estimated glomerular filtration rate [eGFR] ≥60 mL/min/1.73 m2 calculated with the MDRD formula within 72 hours prior to enrollment.
Exclusion Criteria:
Is a pregnant or lactating female.
Has a history of severe congestive heart failure
Has a history of hyperthyroidism
Has a history of hypersensitivity to iodinated contrast agents
Has unstable renal function
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
Prairie Cardiovascular Consultants, Ltd.
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62701
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Kidney Damage in Patients With Normal eGFR
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