A Safety Comparison of Iopromide and Iodixanol in Renal Impaired Patients (DIRECT)

Chinese PLA General Hospital (301 Hospital)

Status and phase

Completed

Phase 4

Conditions

Kidney Failure, Chronic

Treatments

Drug: Iopromide (Ultravist)

Drug: Iodixanol (Visipaque)

Study type

Interventional

Funder types

Other

Identifiers

NCT00926562

14147

Details and patient eligibility

About

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).

Full 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 contrast media, and it may cause kidney toxicity especially in the patients with chronic renal insufficiency.

Enrollment

592 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

18 years old or older
Plan to undergo Cardiac Catheterization
Signed ICF
eGFR: 30~59 mL/min/1.73m2

Exclusion criteria

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