Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  Purpose

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


Condition
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

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:
  • 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


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)
Groups/Cohorts
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.

  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 percutaneous coronary intervention

Criteria

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
  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: NCT01399203

Contacts
Contact: Ning Tan, MD 86-20-83819161 tanning100@126.com
Contact: Yong Liu, MD 86-15920172292 liuyongyisheng@126.com

Locations
China, Guangdong
Ning Tan Recruiting
Guangzhou, Guangdong, China, 510100
Contact: Ning Tan, MD    8620-83819161    tanning100@126.com   
Contact: Yong Liu, MD    8615920172292    liuyongyisheng@126.com   
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
Investigators
Study Director: Yong Liu, MD Guangdong General Hospital
  More Information

No publications provided

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

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

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2014