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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 17 October 2012
Main ID:  NCT01400295
Date of registration: 21/07/2011
Primary sponsor: Guangdong General Hospital
Public title: Predictive Value of Contrast Volume to Creatinine Clearance Ratio PRECOMIN
Scientific title: Predictive Value of the Contrast Media Volume to Creatinine Clearance Ratio for the Risk of Contrast-Induced Nephropathy After Coronary Angiography
Date of first enrolment: December 2010
Target sample size: 5000
Recruitment status: Recruiting
URL:  http://clinicaltrials.gov/show/NCT01400295
Study type:  Observational
Study design:  Observational Model: Cohort, Time Perspective: Prospective  
Countries of recruitment
China
Contacts
Name:   Jiyan Chen, MD
Address: 
Telephone: 86-20-83827812-10528
Email: chenjiyandr@126.com
Affiliation: 
Name:   Jiyan Chen, MD
Address: 
Telephone: 86-20-83827812-10528
Email: chenjiyandr@126.com
Affiliation: 
Name:   Jianfang Luo, MD
Address: 
Telephone:
Email:
Affiliation:  Guangdong Cardiovascular Institute,Guangdong General Hospital
Name:   Jiyan Chen, MD
Address: 
Telephone:
Email:
Affiliation:  Guangdong Cardiovascular Institute,Guangdong General Hospital
Name:   Ning Tan, MD
Address: 
Telephone:
Email:
Affiliation:  Guangdong Cardiovascular Institute,Guangdong General Hospital
Name:   Yingling Zhou, MD
Address: 
Telephone:
Email:
Affiliation:  Guangdong Cardiovascular Institute,Guangdong General Hospital
Name:   Yong Liu, MD
Address: 
Telephone:
Email:
Affiliation:  Guangdong Cardiovascular Institute,Guangdong General Hospital
Key inclusion & exclusion criteria

Inclusion Criteria:

- patients who agreed to stay in the hospital for 2-3 days after coronary angiography

- provided written informed consent

Exclusion Criteria:

- pregnancy

- lactation

- intravascular administration of an contrast medium within the previous seven days

- treatment with metformin,aminoglycosides,N-acetylcysteine (NAC),nonsteroidal
anti-inflammatory drugs within the previous 48 h

- intake of nephrotoxic drugs within the previous seven days

- history of serious reactions to contrast mediums, severe concomitant disease renal
transplantation , or end-stage renal disease necessitating dialysis

- patients who died during coronary angiography



Age minimum: 21 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Contrast Induced Nephropathy
Intervention(s)
Primary Outcome(s)
Contrast-Induced Nephropathy [Time Frame: 48-72 h]
Secondary Outcome(s)
An early abnormal increase in serum creatinine [Time Frame: 24h]
An early abnormal increase in serum cystatin C [Time Frame: 24h]
Major adverse clinical events [Time Frame: 1 year]
Major adverse clinical events [Time Frame: 1month]
Secondary ID(s)
20100917
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Guangdong Medical College
Hainan People's Hospital
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