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Contrast Medium Volume and Contrast-induced Nephropathy After Percutaneous Coronary Intervention (CONVIN)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2010 by Guangdong General Hospital.
Recruitment status was:  Recruiting
Hainan People's Hospital
Guangdong Medical College
Information provided by:
Guangdong General Hospital Identifier:
First received: July 19, 2011
Last updated: August 2, 2011
Last verified: January 2010
To investigate the predictive value of the contrast media volume to creatinine clearance (V/CrCl) ratio for the risk of contrast-induced nephropathy (CIN) (i.e., within 48-72 h) and to determine a relatively safe V/CrCl cut-off value to avoid CIN in patients following PCI

Contrast Induced Nephropathy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Contrast Medium Volume and Contrast-induced Nephropathy After Percutaneous Coronary Intervention

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 ]
    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:
  • 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

Estimated Enrollment: 2000
Study Start Date: January 2010
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
percutaneous coronary intervention
The investigators reviewed all consecutive patients who were undergoing percutaneous coronary intervention

Detailed Description:
contrast media volume to creatinine clearance (V/CrCl) ratios were obtained from consecutive consenting patients after unselective PCI. 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 CIN was assessed using multivariate logistic regression.

Ages Eligible for Study:   21 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 percutaneous coronary intervention

Inclusion Criteria:

  • patients who agreed to stay in the hospital for 2-3 days after percutaneous coronary intervention
  • provided written informed consent
  • Creatinine Clearance:15-60ml/min

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 percutaneous coronary intervention
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Please refer to this study by its identifier: NCT01399203

Contact: Ning Tan, MD 86-20-83819161
Contact: Yong Liu, MD 86-15920172292

China, Guangdong
Ning Tan Recruiting
Guangzhou, Guangdong, China, 510100
Contact: Ning Tan, MD    8620-83819161   
Contact: Yong Liu, MD    8615920172292   
Principal Investigator: Yong Liu, MD         
Principal Investigator: Jiyan Chen, MD         
Principal Investigator: Yingling Zhou, MD         
Principal Investigator: Jianfang Luo, MD         
Principal Investigator: Shuguang Lin, MD         
Sponsors and Collaborators
Guangdong General Hospital
Hainan People's Hospital
Guangdong Medical College
Study Director: Yong Liu, MD Guangdong General Hospital
  More Information

Responsible Party: Ning Tan, MD, Guangdong Cardiovascular Institute,Guangdong General Hospital Identifier: NCT01399203     History of Changes
Other Study ID Numbers: 2009X41
Study First Received: July 19, 2011
Last Updated: August 2, 2011

Keywords provided by Guangdong General Hospital:
contrast-induced nephropathy
contrast medium
creatinine clearance
percutaneous coronary intervention

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases processed this record on May 25, 2017