Overview

Kidney Damage In Patients With Severe Fall In eGFR

Status:
Terminated
Trial end date:
2012-11-01
Target enrollment:
0
Participant gender:
All
Summary
This is a pilot study using a randomized, double blinded, comparison of two iodinated contrast agents used during percutaneous coronary intervention (PCI). All patients enrolled must have and estimated glomerular filtration [eGFR] < 30 mL/min/1.73 m2. Statistical summaries will be presented to analyse the various laboratory tests for the two groups.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Bracco Diagnostics, Inc
Criteria
Inclusion Criteria:

- Provides written Informed Consent

- Is at least 18 years of age;

- Is scheduled for or likely to undergo percutaneous coronary intervention;

- Has documented estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73 m2
calculated with the MDRD formula within 72 hours prior the enrolment.

Exclusion Criteria:

- Is a pregnant or lactating female

- Has a history of severe congestive heart failure

- Has a history of hyperthyroidism

- Has unstable renal function

- Has a history of hypersensitivity to iodinated contrast agents