- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00479024
Follow-up Study to Previous CARE Trial
September 29, 2009 updated by: Bracco Diagnostics, Inc
CARE (Visipaque 320 and Isovue 370 in Cardiac Angiography in REnally Impaired Patients); FOLLOW-UP STUDY
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
294
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Alabama
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Birmingham, Alabama, United States, 35209
- Cardiovascular Associates
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Primary care clinic
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
observation
patients enrolled in previous trial IOP 104; collecting clinical outcome data on these same patients
|
iodinated contrast agent either 370 stength of iopamidol or 320 strength of visipaque
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Steven Sireci, M.D., Bracco Diagnostics, Inc
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2007
Primary Completion (ACTUAL)
December 1, 2007
Study Completion (ACTUAL)
April 1, 2008
Study Registration Dates
First Submitted
May 23, 2007
First Submitted That Met QC Criteria
May 24, 2007
First Posted (ESTIMATE)
May 25, 2007
Study Record Updates
Last Update Posted (ESTIMATE)
September 30, 2009
Last Update Submitted That Met QC Criteria
September 29, 2009
Last Verified
September 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IOP112
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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