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PREdictive Value of COntrast voluMe to creatinINe Clearance Ratio (PRECOMIN)

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ClinicalTrials.gov Identifier: NCT01400295
Recruitment Status : Completed
First Posted : July 22, 2011
Last Update Posted : September 16, 2014
Sponsor:
Information provided by (Responsible Party):
Jiyan Chen, Guangdong General Hospital

Brief Summary:
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 or disease
Contrast Induced Nephropathy

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.

Study Type : Observational
Actual Enrollment : 3000 participants
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
Study Start Date : December 2010
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
coronary angiography
The investigators reviewed 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 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: 1 year ]
    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: 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

  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
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

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): NCT01400295


Locations
China, Guangdong
Guangdong Cardiovascular Institute,Guangdong General Hospital
Guangzhou, Guangdong, China, 510080
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jiyan Chen, MD, Guangdong General Hospital
ClinicalTrials.gov Identifier: NCT01400295     History of Changes
Other Study ID Numbers: 20100917
First Posted: July 22, 2011    Key Record Dates
Last Update Posted: September 16, 2014
Last Verified: September 2014

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

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases