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OpenTrials
Completed

NCT Number: NCT00479024

Follow-up Study to Previous CARE Trial

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cardiovascular Associates

Birmingham, Alabama, 35209, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Iodinated Contrast Agent

Drug

iodinated contrast agent either 370 stength of iopamidol or 320 strength of visipaque

Sponsors and collaborators

Lead sponsor

Bracco Diagnostics, Inc

Industry

Registry information

Official study title

CARE (Visipaque 320 and Isovue 370 in Cardiac Angiography in REnally Impaired Patients); FOLLOW-UP STUDY

Important dates

Study start
2007
Primary completion
2007
Study completion
2008
First posted
May 25, 2007
Registry last updated
Sep 30, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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