Follow-up Study to Previous CARE Trial
This study has been completed.
Sponsor:
Bracco Diagnostics, Inc
Information provided by:
Bracco Diagnostics, Inc
ClinicalTrials.gov Identifier:
NCT00479024
First received: May 23, 2007
Last updated: September 29, 2009
Last verified: September 2009
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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 |
Resource links provided by NLM:
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 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 Kidney Failure, Chronic Urologic Diseases Renal Insufficiency |
ClinicalTrials.gov processed this record on May 16, 2013