Follow-up Study to Previous CARE Trial

Moderate to Severe Chronic Kidney Disease Clinical Trial

Official title:

CARE (Visipaque 320 and Isovue 370 in Cardiac Angiography in REnally Impaired Patients); FOLLOW-UP STUDY

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00479024
• Other study ID #: IOP112
• Status: Completed
• Phase: N/A
• First received: May 23, 2007
• Last updated: September 29, 2009
• Start date: June 2007
• Est. completion date: April 2008

Study information

• Verified date: September 2009
• Source: Bracco Diagnostics, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 294
• Est. completion date: April 2008
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Kidney Diseases
• Moderate to Severe Chronic Kidney Disease
• Renal Insufficiency, Chronic

Intervention

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

Locations

Country	Name	City	State
United States	Cardiovascular Associates	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
Bracco Diagnostics, Inc

Country where clinical trial is conducted

United States,