Follow-up Study to Previous CARE Trial

Completed

• Conditions: Moderate to Severe Chronic Kidney Disease
• Interventions: Drug: iodinated contrast agent

• Registration Number: NCT00479024
• Lead Sponsor: Bracco Diagnostics, Inc

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 available

Study Timeline

• Study First Submitted: 2007-05-23
• Study First Submitted QC: 2007-05-24
• Study First Posted: 2007-05-25
• Study Start: 2007-06
• Primary Completion: 2007-12
• Study Completion: 2008-04
• Status Verified: 2009-09
• Last Update Submitted: 2009-09-29
• Last Update Posted: 2009-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 294

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
observation	iodinated contrast agent	patients enrolled in previous trial IOP 104; collecting clinical outcome data on these same patients

Trial Locations

Locations (1)

Cardiovascular Associates; 🇺🇸 Birmingham, Alabama, United States