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

NCT00823628 | Completed Phase 4

• 1 other identifier: B-0902/069-003
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Renal Insufficiency; Coronary Angiography

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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

Study Arms (2)

iopromide

ACTIVE COMPARATOR

Drug: contrast agent (iopromide)

iodixanol

EXPERIMENTAL

Drug: contrast agent (iodixanol)

Interventions

contrast agent (iopromide) DRUG

coronary angiography using the allocated contrast agent

iopromide

contrast agent (iodixanol) DRUG

coronary angiography using the allocated contrast agent

iodixanol

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• patients who undergo coronary catheterization
• creatinine clearance rates ≤ 60 mL/min using the Cockcroft-Gault formula

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead

Study Sites (1)

Cardiovascular Center, Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Contrast Media; iopromide; iodixanol

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Uses of Chemicals; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Study Officials

• Tae-Jin Youn, MD, PhD

  Facility: Cardiovascular Center, Seoul National University Bundang Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 14, 2009
• First Posted: January 15, 2009
• Study Start: February 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: June 1, 2010
• Last Updated: July 7, 2010

Record last verified: 2009-04

Locations

KR (1)