Follow-up Study to Previous CARE Trial

This study has been completed.
Sponsor:
Information provided by:
Bracco Diagnostics, Inc
ClinicalTrials.gov Identifier:
NCT00479024
First received: May 23, 2007
Last updated: September 29, 2009
Last verified: September 2009
  Purpose

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).


Condition Intervention
Moderate to Severe Chronic Kidney Disease
Drug: iodinated contrast agent

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: CARE (Visipaque 320 and Isovue 370 in Cardiac Angiography in REnally Impaired Patients); FOLLOW-UP STUDY

Further study details as provided by Bracco Diagnostics, Inc:

Enrollment: 294
Study Start Date: June 2007
Study Completion Date: April 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
observation
patients enrolled in previous trial IOP 104; collecting clinical outcome data on these same patients
Drug: iodinated contrast agent
iodinated contrast agent either 370 stength of iopamidol or 320 strength of visipaque

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Primary care clinic

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00479024

Locations
United States, Alabama
Cardiovascular Associates
Birmingham, Alabama, United States, 35209
Sponsors and Collaborators
Bracco Diagnostics, Inc
Investigators
Study Chair: Steven Sireci, M.D. Bracco Diagnostics, Inc
  More Information

No publications provided by Bracco Diagnostics, Inc

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Steven Sireci, Executive Director, Corporate medical Support, Bracco Diagnostics, Inc.
ClinicalTrials.gov Identifier: NCT00479024     History of Changes
Other Study ID Numbers: IOP112
Study First Received: May 23, 2007
Last Updated: September 29, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014