Back to resultsKidney Damage In Patients With Severe Fall In eGFR
Primary Purpose
Coronary Artery Stenosis
Status
Terminated
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Iopamidol 370
Iodixanol 320
Sponsored by
About this trial
This is an interventional diagnostic trial for Coronary Artery Stenosis
Eligibility Criteria
Inclusion Criteria:
- Provides written Informed Consent
- Is at least 18 years of age;
- Is scheduled for or likely to undergo percutaneous coronary intervention;
- Has documented estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73 m2 calculated with the MDRD formula within 72 hours prior the enrolment.
Exclusion Criteria:
- Is a pregnant or lactating female
- Has a history of severe congestive heart failure
- Has a history of hyperthyroidism
- Has unstable renal function
- Has a history of hypersensitivity to iodinated contrast agents
Sites / Locations
- Institu De Cardiologie De Montreal
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
IOPAMIDOL injection 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 in Comparison to a Non-ionic, Iso-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 contrast media.
Secondary Outcome Measures
Full Information
NCT ID
NCT01136915
First Posted
June 2, 2010
Last Updated
February 20, 2014
Sponsor
Bracco Diagnostics, Inc
1. Study Identification
Unique Protocol Identification Number
NCT01136915
Brief Title
Kidney Damage In Patients With Severe Fall In 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 Severe Fall in eGFR Undergoing Percutaneous Coronary Intervention With IOPAMIDOL Injection 370 or IODIXANOL 320
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Terminated
Why Stopped
slow enrollment
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
This is a pilot study using a randomized, double blinded, comparison of two iodinated contrast agents used during percutaneous coronary intervention (PCI). All patients enrolled must have and estimated glomerular filtration [eGFR] < 30 mL/min/1.73 m2. 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
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IOPAMIDOL injection 370
Arm Type
Active Comparator
Arm Title
Iodixanol 320
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Iopamidol 370
Other Intervention Name(s)
Isovue 370
Intervention Description
one time administration for PCI
Intervention Type
Drug
Intervention Name(s)
Iodixanol 320
Intervention Description
Iodixanol 320 single injection for percutaneous coronary injection
Primary Outcome Measure Information:
Title
Impact on the Trajectory of Serum and Urinary NGAL Following the Administration of Non-ionic, Low-osmolar Contrast Media in Comparison to a Non-ionic, Iso-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 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
Is at least 18 years of age;
Is scheduled for or likely to undergo percutaneous coronary intervention;
Has documented estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73 m2 calculated with the MDRD formula within 72 hours prior the enrolment.
Exclusion Criteria:
Is a pregnant or lactating female
Has a history of severe congestive heart failure
Has a history of hyperthyroidism
Has unstable renal function
Has a history of hypersensitivity to iodinated contrast agents
Facility Information:
Facility Name
Institu De Cardiologie De Montreal
City
Montreal
State/Province
Quebec
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Kidney Damage In Patients With Severe Fall In eGFR
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