Moderate to Severe Chronic Kidney Disease
Conditions
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).
Interventions
iodinated contrast agent either 370 stength of iopamidol or 320 strength of visipaque
Sponsors
Bracco Diagnostics, Inc
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Countries
United States
Outcome results
None listed