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
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Condition or disease | Intervention/treatment |
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Moderate to Severe Chronic Kidney Disease | Drug: iodinated contrast agent |
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 |
Group/Cohort | Intervention/treatment |
---|---|
observation
patients enrolled in previous trial IOP 104; collecting clinical outcome data on these same patients
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Drug: iodinated contrast agent
iodinated contrast agent either 370 stength of iopamidol or 320 strength of visipaque |

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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 |
Inclusion Criteria: (from previous CARE trial)
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• 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:
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• 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

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
United States, Alabama | |
Cardiovascular Associates | |
Birmingham, Alabama, United States, 35209 |
Study Chair: | Steven Sireci, M.D. | Bracco Diagnostics, Inc |
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 |
Kidney Diseases Renal Insufficiency, Chronic Urologic Diseases Renal Insufficiency |