Follow-up Study to Previous CARE Trial

NCT00479024 | Completed

• 1 other identifier: IOP112
• Study Type: observational
• Target: 294
• Locations: 1 country
• Sites: 1

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).

Conditions

Moderate to Severe Chronic Kidney Disease

Study Arms (1)

observation

patients enrolled in previous trial IOP 104; collecting clinical outcome data on these same patients

Drug: iodinated contrast agent

Interventions

iodinated contrast agent DRUG

iodinated contrast agent either 370 stength of iopamidol or 320 strength of visipaque

observation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary care clinic

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bracco Diagnostics, Inc: lead

Study Sites (1)

Cardiovascular Associates

Birmingham, Alabama, 35209, United States

Location

Related Publications (1)

• 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.

  PMID: 19556381 DERIVED

Study Officials

• Steven Sireci, M.D.

  Bracco Diagnostics, Inc

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 23, 2007
• First Posted: May 25, 2007
• Study Start: June 1, 2007
• Primary Completion: December 1, 2007
• Study Completion: April 1, 2008
• Last Updated: September 30, 2009

Record last verified: 2009-09

Locations

US (1)