Reduction of Risk for Contrast Nephropathy (REICIN)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Guangdong General Hospital
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
ClinicalTrials.gov Identifier:
NCT01402232
First received: July 25, 2011
Last updated: August 27, 2013
Last verified: August 2013
  Purpose

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
Contrast Induced Nephropathy

Study Type: Observational
Study Design: 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

Further study details as provided by Guangdong General Hospital:

Primary Outcome Measures:
  • contrast-induced nephropathy [ Time Frame: 48-72 h ] [ Designated as safety issue: Yes ]
    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:
  • An early abnormal increase in serum creatinine [ Time Frame: 24h ] [ Designated as safety issue: Yes ]
    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

  • Major adverse clinical events [ Time Frame: 1month ] [ Designated as safety issue: Yes ]
    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

  • Major adverse clinical events [ Time Frame: 1year ] [ Designated as safety issue: Yes ]
    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

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


Estimated Enrollment: 5000
Study Start Date: January 2013
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
coronary angiography
We review all consecutive patients who were undergoing coronary angiography

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Jiyan Chen, MD, Guangdong General Hospital
ClinicalTrials.gov Identifier: NCT01402232     History of Changes
Other Study ID Numbers: Y20110721
Study First Received: July 25, 2011
Last Updated: August 27, 2013
Health Authority: China: Ethics Committee

Keywords provided by 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

ClinicalTrials.gov processed this record on July 24, 2014