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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Guangdong General Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Hainan People's Hospital
Guangdong Medical College
Information provided by:
Guangdong General Hospital
ClinicalTrials.gov Identifier:
NCT01399203
First received: July 19, 2011
Last updated: August 2, 2011
Last verified: January 2010

July 19, 2011
August 2, 2011
January 2010
October 2011   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01399203 on ClinicalTrials.gov Archive Site
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
Same as current
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Contrast Medium Volume and Contrast-induced Nephropathy After Percutaneous Coronary Intervention
Contrast Medium Volume and Contrast-induced Nephropathy After Percutaneous Coronary Intervention

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 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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

The investigators reviewed all consecutive patients who were undergoing percutaneous coronary intervention

Contrast Induced Nephropathy
Not Provided
percutaneous coronary intervention
The investigators reviewed all consecutive patients who were undergoing percutaneous coronary intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2000
January 2012
October 2011   (final data collection date for primary outcome measure)

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
Both
21 Years and older
No
Contact: Ning Tan, MD 86-20-83819161 tanning100@126.com
Contact: Yong Liu, MD 86-15920172292 liuyongyisheng@126.com
China
 
NCT01399203
2009X41
Yes
Ning Tan, MD, Guangdong Cardiovascular Institute,Guangdong General Hospital
Guangdong General Hospital
  • Hainan People's Hospital
  • Guangdong Medical College
Study Director: Yong Liu, MD Guangdong General Hospital
Guangdong General Hospital
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP