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Follow-up Study to Previous CARE Trial

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ClinicalTrials.gov Identifier: NCT00479024
Recruitment Status : Completed
First Posted : May 25, 2007
Last Update Posted : September 30, 2009
Sponsor:
Information provided by:
Bracco Diagnostics, Inc

Tracking Information
First Submitted Date May 23, 2007
First Posted Date May 25, 2007
Last Update Posted Date September 30, 2009
Study Start Date June 2007
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Follow-up Study to Previous CARE Trial
Official Title CARE (Visipaque 320 and Isovue 370 in Cardiac Angiography in REnally Impaired Patients); FOLLOW-UP STUDY
Brief Summary To determine comparative 1-year outcomes in renally impaired patients who previously underwent cardiac angiography with Isovue®-370 or Visipaque™ 320 as part of the IOP-104 trial protocol and were evaluable for determination of post-contrast significant renal injury (defined as >25% increase in SCr or >25% increase in cystatin C).
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Primary care clinic
Condition Moderate to Severe Chronic Kidney Disease
Intervention Drug: iodinated contrast agent
iodinated contrast agent either 370 stength of iopamidol or 320 strength of visipaque
Study Groups/Cohorts observation
patients enrolled in previous trial IOP 104; collecting clinical outcome data on these same patients
Intervention: Drug: iodinated contrast agent
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 3, 2008)
294
Original Estimated Enrollment
 (submitted: May 24, 2007)
425
Actual Study Completion Date April 2008
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria: (from previous CARE trial)

  • • Screening eGFR between 20 and 59 mL/min/1.73m2

    • 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:

  • • Screening eGFR outside the range of 20 and 59 mL/min/1.73m2

    • 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00479024
Other Study ID Numbers IOP112
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Steven Sireci, Executive Director, Corporate medical Support, Bracco Diagnostics, Inc.
Study Sponsor Bracco Diagnostics, Inc
Collaborators Not Provided
Investigators
Study Chair: Steven Sireci, M.D. Bracco Diagnostics, Inc
PRS Account Bracco Diagnostics, Inc
Verification Date September 2009