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Reduction of Risk for Contrast Nephropathy (REICIN)

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ClinicalTrials.gov Identifier: NCT01402232
Recruitment Status : Unknown
Verified August 2015 by Jiyan Chen, Guangdong General Hospital.
Recruitment status was:  Recruiting
First Posted : July 26, 2011
Last Update Posted : August 21, 2015
Sponsor:
Collaborators:
First Affiliated Hospital, Sun Yat-Sen University
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Nanfang Hospital of Southern Medical University
Guangzhou General Hospital of Guangzhou Military Command
Southern Medical University, China
Hainan People's Hospital
Guangdong Medical College
Information provided by (Responsible Party):
Jiyan Chen, Guangdong General Hospital

Brief Summary:
To raise optimal strategies for reduction of risk of contrast-induced nephropathy according to several combinations of different risk factors and clinical practice and determine and supply the guidance for clinical practice

Condition or disease
Contrast Induced Nephropathy

Detailed Description:
  1. To identify risk factors of contrast-induced nephropathy on the base of literatures and the dates of our previous researches.
  2. To develop a predictive model of contrast-induced nephropathy after coronary or percutaneous coronary intervention.
  3. To raise optimal strategies for reduction of risk of contrast-induced nephropathy according to several combinations of different risk factors and clinical practice and determine and supply the guidance for clinical practice.

Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Reduction of Risk for Contrast-Induced Nephropathy: A Multicentre Observational Study of Contrast-Induced Nephropathy Following Coronary Angiography or Percutaneous Coronary Intervention
Study Start Date : January 2013
Estimated Primary Completion Date : September 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
U.S. FDA Resources

Group/Cohort
coronary angiography
We review all consecutive patients who were undergoing coronary angiography



Primary Outcome Measures :
  1. contrast-induced nephropathy [ Time Frame: 48-72 h ]
    Contrast-Induced Nephropathy was defined as an increase in serum creatinine of more than 0.5 mg/dl from the baseline within 48-72 h of contrast exposure


Secondary Outcome Measures :
  1. An early abnormal increase in serum creatinine [ Time Frame: 24h ]
    An early abnormal increase in serum creatinine in serum defined as an increase in serum creatinine of more than 0.5 mg/dl from the baseline within 24h of contrast exposure

  2. Major adverse clinical events [ Time Frame: 1month ]
    Major adverse clinical events: death, requiring renal replacement therapy, 2nd myocardial infarction,target revascularization,acute heart failure, mechanical ventilation,2nd angina,tachyarrhythmia,hypotension,intra-aortic balloon pump and stroke

  3. Major adverse clinical events [ Time Frame: 1year ]
    Major adverse clinical events: death, requiring renal replacement therapy, 2nd myocardial infarction,target revascularization,acute heart failure, mechanical ventilation,2nd angina,tachyarrhythmia,hypotension,intra-aortic balloon pump and stroke

  4. An early abnormal increase in serum cystatin C [ Time Frame: 24h ]
    An early abnormal increase in serum cystatin C was defined as an increase more than 10% from the baseline within 24h of contrast exposure



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
We reviewed all consecutive patients who were undergoing coronary angiography
Criteria

Inclusion Criteria:

  • patients who agreed to stay in the hospital for 1-3 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01402232


Contacts
Contact: Jiyan Chen, MD 86-20-83827812-10528 chenjiyandr@126.com
Contact: Yingling Zhou, MD 86-20-83827812-10520 gdhzyl@yahoo.com.cn

Locations
China, Guangdong
Guangdong General Hospital Recruiting
Guangzhou, Guangdong, China, 510100
Contact: Jiyan Chen, MD    8620-83827812 ext 10528    chenjiyandr@126.com   
Contact: Yong Liu, MD    8615920172292    liuyongyisheng@126.com   
Principal Investigator: Yingling Zhou, MD         
Principal Investigator: Ning Tan, MD         
Sponsors and Collaborators
Guangdong General Hospital
First Affiliated Hospital, Sun Yat-Sen University
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Nanfang Hospital of Southern Medical University
Guangzhou General Hospital of Guangzhou Military Command
Southern Medical University, China
Hainan People's Hospital
Guangdong Medical College
Investigators
Study Chair: Jiyan Chen, MD Guangdong Cardiovascular Institute,Guangdong General Hospital
Study Director: Yingling Zhou, MD Guangdong Cardiovascular Institute,Guangdong General Hospital
Study Director: Yong Liu, MD Guangdong Cardiovascular Institute,Guangdong General Hospital
Study Director: Ning Tan, MD Guangdong Cardiovascular Institute,Guangdong General Hospital
Study Director: Pingyan Chen, Professor Southern Medical University, China

Responsible Party: Jiyan Chen, MD, Guangdong General Hospital
ClinicalTrials.gov Identifier: NCT01402232     History of Changes
Other Study ID Numbers: Y20110721
First Posted: July 26, 2011    Key Record Dates
Last Update Posted: August 21, 2015
Last Verified: August 2015

Keywords provided by Jiyan Chen, Guangdong General Hospital:
contrast-induced nephropathy
contrast medium
creatinine clearance
coronary angiography
diabetes
chronic kidney disease
predictive model

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases