Predictive Value of Contrast Volume to Creatinine Clearance Ratio (PRECOMIN)

This study is currently recruiting participants.
Verified August 2013 by Guangdong General Hospital
Sponsor:
Information provided by (Responsible Party):
Jiyan Chen, Guangdong General Hospital
ClinicalTrials.gov Identifier:
NCT01400295
First received: July 21, 2011
Last updated: August 27, 2013
Last verified: August 2013
  Purpose

To determine a relatively safe contrast media volume to creatinine clearance cut-off value to avoid contrast-induced nephropathy in patients following coronary angiography


Condition
Contrast Induced Nephropathy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Predictive Value of the Contrast Media Volume to Creatinine Clearance Ratio for the Risk of Contrast-Induced Nephropathy After Coronary Angiography

Resource links provided by NLM:


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 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: 1 year ] [ 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: 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

  • 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: December 2010
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
coronary angiography
The investigators reviewed all consecutive patients who were undergoing coronary angiography

Detailed Description:

Contrast media volume to creatinine clearance (V/CrCl) ratios were obtained from consecutive consenting patients after coronary angiography. Receiver-operator characteristic (ROC) curves were used to identify the optimal sensitivity for the observed range of V/CrCl. The predictive value of V/CrCl for the risk of contrast-induced nephropathy was assessed using multivariate logistic regression.Subgroup analysis was performed on patients with creatinine clearance < 60 ml/min,diabetes,emergent angiography.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

The investigators reviewed all consecutive patients who were undergoing coronary angiography

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01400295

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 Cardiovascular Institute,Guangdong General Hospital Recruiting
Guangzhou, Guangdong, China, 510080
Contact: Jiyan Chen, MD    86-20-83827812-10528    chenjiyandr@126.com   
Contact: Yong Liu, MD    8615920172292    liuyongyisheng@126.com   
Principal Investigator: Yingling Zhou, MD         
Principal Investigator: Ning Tan, MD         
Principal Investigator: Jianfang Luo, MD         
Principal Investigator: Zhujun Chen, MD         
Sub-Investigator: Keng Wu, MD         
Sub-Investigator: Chunyan Jian, MD         
Sub-Investigator: Yao Dong, MD         
Sponsors and Collaborators
Guangdong General Hospital
Investigators
Study Chair: Jiyan Chen, MD Guangdong Cardiovascular Institute,Guangdong General Hospital
Study Director: Yong Liu, MD Guangdong Cardiovascular Institute,Guangdong General Hospital
Study Director: Yingling Zhou, MD Guangdong Cardiovascular Institute,Guangdong General Hospital
Study Director: Ning Tan, MD Guangdong Cardiovascular Institute,Guangdong General Hospital
Principal Investigator: Jianfang Luo, MD Guangdong Cardiovascular Institute,Guangdong General Hospital
  More Information

No publications provided

Responsible Party: Jiyan Chen, MD, Guangdong General Hospital
ClinicalTrials.gov Identifier: NCT01400295     History of Changes
Other Study ID Numbers: 20100917
Study First Received: July 21, 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

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on April 17, 2014