Renal Effects of Two Iodinated Contrast Media in Patients at Risk Undergoing Coronary Angiography

NCT00209430 | Completed Phase 4

• 1 other identifier: DXV405
• Study Type: interventional
• Target: 408
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of this study is to evaluate and compare the effects on kidney function of two contrast media, the iso-osmolar iodixanol and the low-osmolar iopamidol in patients at risk of kidney damage associated with the injection of contrast media. A standard hydration procedure, based on available guidelines will be given to all patients to prevent negative effects on the kidneys. Serum creatinine (SCr ) concentrations will be measured before and up to 7 days after contrast media administration to evaluate the effects on renal function.

Conditions

Coronary Artery Disease; Renal Impairment

Keywords

Iodixanol; Iopamidol; coronary angiography; Contrast media-induced nephropathy

Outcome Measures

Primary Outcomes (2)

• Peak increase in SCr

• Incidence of contrast media-induced nephropathy from baseline up to day 3.

Secondary Outcomes (3)

• SCr concentrations up to days 3 and 7

• image quality

• occurrence of adverse events and their severity and relationship with the contrast media.

Interventions

Iodixanol 320 mgI/mL DRUG

Eligibility Criteria

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

You may qualify if:

• Subjects with a combination of diabetes mellitus (type I or II) and renal impairment, defined as serum creatinine (SCr ) ≥150 µmol/L (1.7 mg/dL) for men and ≥133 µmol/L (1.5 mg/dL) for women or creatinine clearance (CrCl) ≤ 50 mL/min calculated according to Cockroft-Gault formula, referred for coronary angiography with or without PCI.

You may not qualify if:

• Concurrent administration of potentially nephroprotective or nephrotoxic drugs is not allowed. Subjects undergoing dialysis or kidney transplant will not be included.

Sponsors & Collaborators

• GE Healthcare: lead

Study Sites (1)

Amersham Health S.A

Solna, Sweden

Location

Related Publications (1)

• Laskey W, Aspelin P, Davidson C, Rudnick M, Aubry P, Kumar S, Gietzen F, Wiemer M; DXV405 Study Group. Nephrotoxicity of iodixanol versus iopamidol in patients with chronic kidney disease and diabetes mellitus undergoing coronary angiographic procedures. Am Heart J. 2009 Nov;158(5):822-828.e3. doi: 10.1016/j.ahj.2009.08.016.

  PMID: 19853704 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Renal Insufficiency

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Caroline Widlund, BSc RN

  GE Healthcare

  STUDY DIRECTOR

• Johnny Gibbs, Jr., B.S., CCRA

  609-514-6809

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: August 1, 2005
• Last Updated: October 31, 2007

Record last verified: 2007-10

Locations

SE (1)