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

A Randomized, Double-blinded Comparison of Iopromide and Iodixanol in Renally Impaired Patients Undergoing Cardiac Catheterization

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).

Study Overview

• Status: Completed
• Conditions: Kidney Failure, Chronic
• Intervention / Treatment: Drug: Iopromide (Ultravist); Drug: Iodixanol (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.

• Study Type: Interventional
• Enrollment (Actual): 592
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100191
      • Peking University Third Hospital
    • Beijing, Beijing, China, 100853
      • Chinese PLA General Hospital
    • Beijing, Beijing, China, 100020
      • Beijing Chao-Yang Hospital
    • Beijing, Beijing, China, 100730
      • Beijing Hospital
    • Beijing, Beijing, China, 100039
      • General Hospital of Armed Police Forces
    • Beijing, Beijing, China, 10040
      • Beijing Shi Jing Shan Hospital
  • Henan
    • Zhengzhou, Henan, China, 450052
      • The First Affiliated Hospital of Zhengzhou University
    • Zhengzhou, Henan, China, 450003
      • HeNan Provincial People's Hospital
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Wuhan Asia Heart Hospital
  • Hunan
    • Changsha, Hunan, China, 410013
      • The Second Hospital of Xiangya
  • Jilin
    • Changchun, Jilin, China, 130033
      • China-Japan Union Hospital of Jilin University
  • Jinlin
    • Changchun, Jinlin, China, 130021
      • The First Hospital of Jilin University
  • Shanghai
    • Shanghai, Shanghai, China, 200080
      • Shanghai First People's Hospital
    • Shanghai, Shanghai, China, 200127
      • Renji Hospital Affiliated to Shanghai Jiao Tong University
    • Shanghai, Shanghai, China, 200433
      • Changhai Hospital affiliated to the second millitary medical university
  • Tianjin
    • Tianjin, Tianjin, China, 300051
      • Tianjin Chest Hospital
    • Tianjin, Tianjin, China, 300457
      • TEDA International Cardiovascular Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • The Second Hospital Affiliated to Zhejiang University
    • Hangzhou, Zhejiang, China, 310016
      • Sir Run Run Shaw Hospital affiliated to Zhejiang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: Visipaque

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients exhibiting a relative increase in serum creatinine >= 50% from baseline.	day 3 postreatment

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients developing acute renal failure.	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%	days 3

Collaborators and Investigators

• Sponsor: Chinese PLA General Hospital

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: June 19, 2009
• First Submitted That Met QC Criteria: June 22, 2009
• First Posted (Estimate): June 23, 2009

Study Record Updates

• Last Update Posted (Estimate): June 27, 2011
• Last Update Submitted That Met QC Criteria: June 24, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Keywords: Contrast Induced Nephropathy; CIN; Cardiac Catheterization
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Renal Insufficiency
• Other Study ID Numbers: 14147