Status:
COMPLETED
A Safety Comparison of Iopromide and Iodixanol in Renal Impaired Patients
Lead Sponsor:
Chinese PLA General Hospital
Conditions:
Kidney Failure, Chronic
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The investigators intend to find out which contrast agent has less kidney toxicity in renal impaired patients undergoing cardiac angiography or percutaneous coronary intervention (PCI).
Detailed Description
In the diagnosis and treatment of coronary heart disease, patients should undergo cardiac angiography or percutaneous coronary intervention (PCI). In those procedures, the investigators should use the...
Eligibility Criteria
Inclusion
- 18 years old or older
- Plan to undergo Cardiac Catheterization
- Signed ICF
- eGFR: 30\~59 mL/min/1.73m2
Exclusion
- Pregnancy
- Under dialysis
- Conditions interfering with Cardiac Catheterization
- Participation in other trials
- Allergic to X-ray contrast media
- Administration of any investigational drug within the previous 30 days
- Intra-arterial or intravenous administration of iodinated contrast medium from 7 days before to 72 hours after the administration of study drug
- Left ventricular ejection fraction (LVEF) less than 30% by ultrasound examination
- Intake of any nephrotoxic medications 24 hours before or after the administration of study drug
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
592 Patients enrolled
Trial Details
Trial ID
NCT00926562
Start Date
February 1 2009
End Date
May 1 2011
Last Update
June 27 2011
Active Locations (19)
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1
Beijing CHAO-YANG Hospital
Beijing, Beijing Municipality, China, 100020
2
General Hospital of Armed Police Forces
Beijing, Beijing Municipality, China, 100039
3
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100191
4
Beijing Shi Jing Shan Hospital
Beijing, Beijing Municipality, China, 10040