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Follow-up Study to Previous CARE Trial

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

Study Description
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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).

Condition or disease Intervention/treatment
Moderate to Severe Chronic Kidney Disease Drug: iodinated contrast agent

Study Design
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Study Type : Observational
Actual Enrollment : 294 participants
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
Study Start Date : June 2007
Actual Primary Completion Date : December 2007
Actual Study Completion Date : April 2008
Groups and Cohorts
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Group/Cohort Intervention/treatment
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


Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00479024


Locations
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United States, Alabama
Cardiovascular Associates
Birmingham, Alabama, United States, 35209
Sponsors and Collaborators
Bracco Diagnostics, Inc
Investigators
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Study Chair: Steven Sireci, M.D. Bracco Diagnostics, Inc
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Steven Sireci, Executive Director, Corporate medical Support, Bracco Diagnostics, Inc.
ClinicalTrials.gov Identifier: NCT00479024    
Other Study ID Numbers: IOP112
First Posted: May 25, 2007    Key Record Dates
Last Update Posted: September 30, 2009
Last Verified: September 2009
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency