Clinical trial NCT00926562: A Safety Comparison of Iopromide and Iodixanol in Renal Impaired Patients
Official title: A Randomized, Double-blinded Comparison of Iopromide and Iodixanol in Renally Impaired Patients Undergoing Cardiac Catheterization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Kidney Failure, Chronic
Keywords: Contrast Induced Nephropathy
CIN
Cardiac Catheterization
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2009-06-23
Enrollment: 592
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Proportion of patients exhibiting a relative increase in serum creatinine >= 50% from baseline.
timeFrame: day 3 postreatment
Secondary outcomes:
measure: Proportion of patients developing acute renal failure.
timeFrame: day 30 postreatment
measure: 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%
timeFrame: days 3
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing CHAO-YANG Hospital
state: Beijing
city: Beijing
country: China
facility: General Hospital of Armed Police Forces
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Shi Jing Shan Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Hospital
state: Beijing
city: Beijing
country: China
facility: Chinese PLA general hospital
state: Beijing
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Wuhan
country: China
facility: Wuhan Asia Heart Hospital
state: Hubei
city: Changsha
country: China
facility: The Second Hospital of Xiangya
state: Hunan
city: Changchun
country: China
facility: China-Japan Union Hospital of Jilin University
state: Jilin
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jinlin
city: Shanghai
country: China
facility: Shanghai First People's Hospital
state: Shanghai
city: Shanghai
country: China
facility: Renji Hospital affiliated to Shanghai Jiao Tong University
state: Shanghai
city: Shanghai
country: China
facility: Changhai Hospital affiliated to the second millitary medical university
state: Shanghai
city: Tianjin
country: China
facility: Tianjin Chest Hospital
state: Tianjin
city: Tianjin
country: China
facility: Teda International Cardiovascular Hospital
state: Tianjin
city: Hangzhou
country: China
facility: The Second Hospital Affiliated to Zhejiang University
state: Zhejiang
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital affiliated to Zhejiang
state: Zhejiang
Study officials:
affiliation: Chinese PLA General Hospital
name: Yundai Chen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.