Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE4
57 participants
INTERVENTIONAL
2010-11-30
2012-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
TRIPLE
Study Groups
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Iopamidol
Non-ionic low-osmolar iodinated contrast media
Iopamidol
Iopamidol 370, one time administration for percutaneous coronary intervention
Iodixanol
Non-ionic iso-osmolar iodinated contrast media comparator
Iodixanol-320
Iodixanol-320 single administration for percutaneous coronary intervention procedure
Interventions
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Iopamidol
Iopamidol 370, one time administration for percutaneous coronary intervention
Iodixanol-320
Iodixanol-320 single administration for percutaneous coronary intervention procedure
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Bracco Diagnostics, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Maria Luigia Storto, MD
Role: STUDY_DIRECTOR
Bracco Diagnostics, Inc
Locations
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Research Cooperative, St. John's Hospital
Springfield, Illinois, United States
UMDNJ - RWJ Medical School
New Brunswick, New Jersey, United States
The Institute for Clinical Research at Holy Name Medical Center
Teaneck, New Jersey, United States
Montreal Heart Institute
Montreal, Quebec, Canada
Countries
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Other Identifiers
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IOP-117
Identifier Type: -
Identifier Source: org_study_id