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

This study has been completed.
Sponsor:
Information provided by:
Chinese PLA General Hospital
ClinicalTrials.gov Identifier:
NCT00926562
First received: June 19, 2009
Last updated: June 24, 2011
Last verified: June 2011
  Purpose

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).


Condition Intervention Phase
Kidney Failure, Chronic
Drug: Iopromide (Ultravist)
Drug: Iodixanol (Visipaque)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized, Double-blinded Comparison of Iopromide and Iodixanol in Renally Impaired Patients Undergoing Cardiac Catheterization

Resource links provided by NLM:


Further study details as provided by Chinese PLA General Hospital:

Primary Outcome Measures:
  • Proportion of patients exhibiting a relative increase in serum creatinine >= 50% from baseline. [ Time Frame: day 3 postreatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Proportion of patients developing acute renal failure. [ Time Frame: day 30 postreatment ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 592
Study Start Date: February 2009
Study Completion Date: May 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Iopromide
Drug: Ultravist 370 mgl/ml, injection of intra-artery during cardiac interventional operation
Drug: Iopromide (Ultravist)
Iopromide (contrast agent), 370 mgl/ml, an nonionic, monomeric, LOCM
Other Name: Ultravist
Active Comparator: Iodixanol
Drug: Visipaque 320 mgl/ml, injection of intra-artery
Drug: Iodixanol (Visipaque)
Iodixanol (contrast agent) 320 mgl/ml, a nonionic, dimeric, IOCM
Other Name: Visipaque

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00926562

Locations
China, Beijing
Chinese PLA general hospital
Beijing, Beijing, China, 100853
Beijing Hospital
Beijing, Beijing, China, 100730
Peking University Third Hospital
Beijing, Beijing, China, 100191
Beijing CHAO-YANG Hospital
Beijing, Beijing, China, 100020
General Hospital of Armed Police Forces
Beijing, Beijing, China, 100039
Beijing Shi Jing Shan Hospital
Beijing, Beijing, China, 10040
China, Henan
Henan Provincial People's Hospital
Zhengzhou, Henan, China, 450003
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450052
China, Hubei
Wuhan Asia Heart Hospital
Wuhan, Hubei, China, 430022
China, Hunan
The Second Hospital of Xiangya
Changsha, Hunan, China, 410013
China, Jilin
China-Japan Union Hospital of Jilin University
Changchun, Jilin, China, 130033
China, Jinlin
The First Hospital of Jilin University
Changchun, Jinlin, China, 130021
China, Shanghai
Shanghai First People's Hospital
Shanghai, Shanghai, China, 200080
Changhai Hospital affiliated to the second millitary medical university
Shanghai, Shanghai, China, 200433
Renji Hospital affiliated to Shanghai Jiao Tong University
Shanghai, Shanghai, China, 200127
China, Tianjin
Tianjin Chest Hospital
Tianjin, Tianjin, China, 300051
Teda International Cardiovascular Hospital
Tianjin, Tianjin, China, 300457
China, Zhejiang
Sir Run Run Shaw Hospital affiliated to Zhejiang
Hangzhou, Zhejiang, China, 310016
The Second Hospital Affiliated to Zhejiang University
Hangzhou, Zhejiang, China, 310009
Sponsors and Collaborators
Chinese PLA General Hospital
Investigators
Principal Investigator: Yundai Chen, MD Chinese PLA General Hospital
  More Information

No publications provided by Chinese PLA General Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Yundai Chen, Chinese PLA general hospital
ClinicalTrials.gov Identifier: NCT00926562     History of Changes
Other Study ID Numbers: 14147
Study First Received: June 19, 2009
Last Updated: June 24, 2011
Health Authority: China: Food and Drug Administration

Keywords provided by Chinese PLA General Hospital:
Contrast Induced Nephropathy
CIN
Cardiac Catheterization

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases
Iodixanol
Iopromide
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 14, 2014