Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
294 participants
OBSERVATIONAL
2007-06-30
2008-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
RETROSPECTIVE
Study Groups
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observation
patients enrolled in previous trial IOP 104; collecting clinical outcome data on these same patients
iodinated contrast agent
iodinated contrast agent either 370 stength of iopamidol or 320 strength of visipaque
Interventions
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iodinated contrast agent
iodinated contrast agent either 370 stength of iopamidol or 320 strength of visipaque
Eligibility Criteria
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Inclusion Criteria
* Baseline SCr obtained within 72 hours and before hydration or, if obtained after hydration started, had the screening blood sample obtained within 72 hours of contrast administration
* At least one post dose blood sample available
* Received randomized contrast agent
* Underwent only one cardiac angiography procedure (diagnostic cardiac angiography followed by PCI was considered as one procedure if confirmed by investigator and total duration does not exceed 12 hours), then for this study
* Provides written Informed Consent and is willing to comply with protocol requirements;
* Was included in the patient list provided by Bracco;
* At least 1 year has passed since the patient's participation ended in the original CARE trial, as determined from the list provided by Bracco
Exclusion Criteria
* Unstable kidney disease or requiring dialysis upon enrollment
* Prior to the post-dose blood draw, suffered a critical clinical event that would affect the reliability of serological measurement of renal function
* Did not receive randomized contrast agent per CARE protocol
* Did not undergo a cardiac angiography procedure per CARE protocol
18 Years
ALL
No
Sponsors
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Bracco Diagnostics, Inc
INDUSTRY
Responsible Party
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Bracco Diagnostics, Inc.
Principal Investigators
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Steven Sireci, M.D.
Role: STUDY_CHAIR
Bracco Diagnostics, Inc
Locations
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Cardiovascular Associates
Birmingham, Alabama, United States
Countries
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References
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Solomon RJ, Mehran R, Natarajan MK, Doucet S, Katholi RE, Staniloae CS, Sharma SK, Labinaz M, Gelormini JL, Barrett BJ. Contrast-induced nephropathy and long-term adverse events: cause and effect? Clin J Am Soc Nephrol. 2009 Jul;4(7):1162-9. doi: 10.2215/CJN.00550109. Epub 2009 Jun 25.
Other Identifiers
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IOP112
Identifier Type: -
Identifier Source: org_study_id