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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00926562
Recruitment Status : Completed
First Posted : June 23, 2009
Last Update Posted : June 27, 2011
Sponsor:
Information provided by:
Chinese PLA General Hospital

Tracking Information
First Submitted Date  ICMJE June 19, 2009
First Posted Date  ICMJE June 23, 2009
Last Update Posted Date June 27, 2011
Study Start Date  ICMJE February 2009
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 24, 2011)
Proportion of patients exhibiting a relative increase in serum creatinine >= 50% from baseline. [ Time Frame: day 3 postreatment ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 22, 2009)
relative increase of Serum Creatinine [ Time Frame: 30 days ]
Change History Complete list of historical versions of study NCT00926562 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 24, 2011)
  • Proportion of patients developing acute renal failure. [ Time Frame: day 30 postreatment ]
  • Incidence of a postdose SCr increase ≧25%, a postdose SCr increase ≧1mg/dL, a postdose SCr increase ≧0.5mg/dL, a postdose eGFR decrease ≧25% [ Time Frame: days 3 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 22, 2009)
increase of Serum Creatinine [ Time Frame: 30 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Safety Comparison of Iopromide and Iodixanol in Renal Impaired Patients
Official Title  ICMJE A Randomized, Double-blinded Comparison of Iopromide and Iodixanol in Renally Impaired Patients Undergoing Cardiac Catheterization
Brief Summary 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).
Detailed 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Kidney Failure, Chronic
Intervention  ICMJE
  • Drug: Iopromide (Ultravist)
    Iopromide (contrast agent), 370 mgl/ml, an nonionic, monomeric, LOCM
    Other Name: Ultravist
  • Drug: Iodixanol (Visipaque)
    Iodixanol (contrast agent) 320 mgl/ml, a nonionic, dimeric, IOCM
    Other Name: Visipaque
Study Arms  ICMJE
  • Experimental: Iopromide
    Drug: Ultravist 370 mgl/ml, injection of intra-artery during cardiac interventional operation
    Intervention: Drug: Iopromide (Ultravist)
  • Active Comparator: Iodixanol
    Drug: Visipaque 320 mgl/ml, injection of intra-artery
    Intervention: Drug: Iodixanol (Visipaque)
Publications * Chen Y, Hu S, Liu Y, Zhao R, Wang L, Fu G, He Q, Su X, Zheng Y, Qi X, Liu H, Wang J, Gao W, Wang M, Liu S, Zheng X, He B, Yang P, Zhou S, Gao C, Qiu C. Renal tolerability of iopromide and iodixanol in 562 renally impaired patients undergoing cardiac catheterisation: the DIRECT study. EuroIntervention. 2012 Nov 22;8(7):830-8. doi: 10.4244/EIJV8I7A126.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 24, 2011)
592
Original Estimated Enrollment  ICMJE
 (submitted: June 22, 2009)
590
Actual Study Completion Date  ICMJE May 2011
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00926562
Other Study ID Numbers  ICMJE 14147
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prof. Yundai Chen, Chinese PLA general hospital
Study Sponsor  ICMJE Chinese PLA General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Yundai Chen, MD Chinese PLA General Hospital
PRS Account Chinese PLA General Hospital
Verification Date June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP