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
1 other identifier
interventional
592
1 country
19
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Feb 2009
Typical duration for phase_4
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 19, 2009
CompletedFirst Posted
Study publicly available on registry
June 23, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedJune 27, 2011
June 1, 2011
1.8 years
June 19, 2009
June 24, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of patients exhibiting a relative increase in serum creatinine >= 50% from baseline.
day 3 postreatment
Secondary Outcomes (2)
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
Study Arms (2)
Iopromide
EXPERIMENTALDrug: Ultravist 370 mgl/ml, injection of intra-artery during cardiac interventional operation
Iodixanol
ACTIVE COMPARATORDrug: Visipaque 320 mgl/ml, injection of intra-artery
Interventions
Iopromide (contrast agent), 370 mgl/ml, an nonionic, monomeric, LOCM
Iodixanol (contrast agent) 320 mgl/ml, a nonionic, dimeric, IOCM
Eligibility Criteria
You may qualify if:
- years old or older
- Plan to undergo Cardiac Catheterization
- Signed ICF
- eGFR: 30\~59 mL/min/1.73m2
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
Beijing CHAO-YANG Hospital
Beijing, Beijing Municipality, 100020, China
General Hospital of Armed Police Forces
Beijing, Beijing Municipality, 100039, China
Peking University Third Hospital
Beijing, Beijing Municipality, 100191, China
Beijing Shi Jing Shan Hospital
Beijing, Beijing Municipality, 10040, China
Beijing Hospital
Beijing, Beijing Municipality, 100730, China
Chinese PLA general hospital
Beijing, Beijing Municipality, 100853, China
Henan Provincial People's Hospital
Zhengzhou, Henan, 450003, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052, China
Wuhan Asia Heart Hospital
Wuhan, Hubei, 430022, China
The Second Hospital of Xiangya
Changsha, Hunan, 410013, China
China-Japan Union Hospital of Jilin University
Changchun, Jilin, 130033, China
The First Hospital of Jilin University
Changchun, Jinlin, 130021, China
Shanghai First People's Hospital
Shanghai, Shanghai Municipality, 200080, China
Renji Hospital affiliated to Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 200127, China
Changhai Hospital affiliated to the second millitary medical university
Shanghai, Shanghai Municipality, 200433, China
Tianjin Chest Hospital
Tianjin, Tianjin Municipality, 300051, China
Teda International Cardiovascular Hospital
Tianjin, Tianjin Municipality, 300457, China
The Second Hospital Affiliated to Zhejiang University
Hangzhou, Zhejiang, 310009, China
Sir Run Run Shaw Hospital affiliated to Zhejiang
Hangzhou, Zhejiang, 310016, China
Related Publications (1)
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.
PMID: 23045301DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yundai Chen, MD
Chinese PLA General Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 19, 2009
First Posted
June 23, 2009
Study Start
February 1, 2009
Primary Completion
December 1, 2010
Study Completion
May 1, 2011
Last Updated
June 27, 2011
Record last verified: 2011-06