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

NCT ID: NCT00823628

Last Updated: 2010-07-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 420 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2010-06-30

Brief 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

Detailed 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.

Conditions

Chronic Renal Insufficiency; Coronary Angiography

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

iopromide

Group Type: ACTIVE_COMPARATOR

contrast agent (iopromide)

Intervention Type: DRUG

coronary angiography using the allocated contrast agent

iodixanol

Group Type: EXPERIMENTAL

contrast agent (iodixanol)

Intervention Type: DRUG

coronary angiography using the allocated contrast agent

Interventions

contrast agent (iopromide)

coronary angiography using the allocated contrast agent

Intervention Type: DRUG

contrast agent (iodixanol)

coronary angiography using the allocated contrast agent

Intervention Type: DRUG

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Bundang Hospital

OTHER

Sponsor Role: lead

Responsible Party

Cardiovascular Center, Seoul National University Bundang Hospital

Principal Investigators

Tae-Jin Youn, MD, PhD

Role: STUDY_DIRECTOR

Facility: Cardiovascular Center, Seoul National University Bundang Hospital

Locations

Cardiovascular Center, Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Countries

South Korea

Other Identifiers

B-0902/069-003

Identifier Type: -

Identifier Source: org_study_id