Contrast-medium Induced Nephrotoxicity in Patients Undergoing Coronary Angiography - Iodixanol Versus Iopromide

Chronic Renal Insufficiency Clinical Trial

Official title:

Comparison of Contrast-medium Induced Nephrotoxicity Between Iodixanol and Iopromide in Patients With Renal Insufficiency Undergoing Coronary Angiography

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00823628
• Other study ID #: B-0902/069-003
• Status: Completed
• Phase: Phase 4
• First received: January 14, 2009
• Last updated: July 6, 2010
• Start date: February 2009
• Est. completion date: June 2010

Study information

• Verified date: April 2009
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Republic of Korea: Seoul National University Bundang Hospital
• Study type: Interventional

Clinical Trial Summary

In the treatment of coronary heart disease which is the major cause of heart attack, direct mechanical treatment with catheters such as the coronary angiography, coronary balloon intervention and stenting intervention are the mainstay of therapy in recent years. In that procedures, the investigators should use the contrast media, and it may cause kidney toxicity especially in the patients with underlying kidney disease and decreased kidney function. The investigators intended to find out which contrast agent has less kidney toxicity in the catheter based treatment of coronary arterial diseases in patients with underlying decreased kidney function

Description:

Iodixanol, a nonionic, dimeric, iso-osmolar contrast medium (IOCM), may be less nephrotoxic than nonionic, monomeric, low-osmolar contrast media (LOCMs) in high-risk patients. We compared the nephrotoxicity of iodixanol with that of iopromide, an nonionic, monomeric LOCM, in patients with renal impairment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 420
• Est. completion date: June 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• patients who undergo coronary catheterization

• creatinine clearance rates = 60 mL/min using the Cockcroft-Gault formula

Exclusion Criteria:

• pregnancy or lactation

• having received contrast media within 7 days of study entry

• emergent coronary angiography

• acute renal failure or end-stage renal disease requiring dialysis

• history of hypersensitivity reaction to contrast media

• unstable hemodynamic states such as cardiogenic shock, pulmonary edema or needing mechanical ventilation

• multiple myeloma

• parenteral use of diuretics

• use of N-acetylcysteine

• use of metformin or nonsteroidal anti-inflammatory drugs within 48 hours of the procedure

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Renal Insufficiency
• Coronary Angiography
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Drug:
• contrast agent (iopromide)
coronary angiography using the allocated contrast agent
• contrast agent (iodixanol)
coronary angiography using the allocated contrast agent

Locations

Country	Name	City	State
Korea, Republic of	Cardiovascular Center, Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of contrast induced nephropathy, defined as either a relative increase in serum creatinine from baseline of >=25% or an absolute increase of >=0.5mg/dL(44.2µmol/L)		days 1 and 2	Yes
Secondary	proportion of patients exhibiting an increase in serum creatinine of >=0.5mg/dL(44.2µmol/L), the proportion with a >=1.0 mg/dL(88.4µmol/L) increase in serum creatinine, and the mean peak increase in serum creatinine		days 1 and 2	Yes