Follow-up Study to Previous CARE Trial

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

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

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