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

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

Study Overview

• Status: Unknown
• Conditions: Contrast Induced Nephropathy

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.

• Study Type: Observational
• Enrollment (Anticipated): 2000

Contacts and Locations

• Study Contact: Name: Ning Tan, MD; Phone Number: 86-20-83819161; Email: tanning100@126.com
• Study Contact Backup: Name: Yong Liu, MD; Phone Number: 86-15920172292; Email: liuyongyisheng@126.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510100
      • Recruiting
      • Ning Tan
      • Contact: Ning Tan, MD; Phone Number: 8620-83819161; Email: tanning100@126.com
      • Contact: Yong Liu, MD; Phone Number: 8615920172292; Email: liuyongyisheng@126.com
      • Principal Investigator: Yong Liu, MD
      • Principal Investigator: Yingling Zhou, MD
      • Principal Investigator: Jianfang Luo, MD
      • Principal Investigator: Shuguang Lin, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
percutaneous coronary intervention; The investigators reviewed all consecutive patients who were undergoing percutaneous coronary intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Contrast-Induced Nephropathy	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	48-72 h

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major adverse clinical events	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	1 year

Collaborators and Investigators

• Sponsor: Guangdong Provincial People's Hospital
• Collaborators: Guangdong Medical College; Hainan People's Hospital
• Investigators: Study Director: Yong Liu, MD, Guangdong Provincial People's Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (ANTICIPATED): October 1, 2011
• Study Completion (ANTICIPATED): January 1, 2012

Study Registration Dates

• First Submitted: July 19, 2011
• First Submitted That Met QC Criteria: July 20, 2011
• First Posted (ESTIMATE): July 21, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): August 3, 2011
• Last Update Submitted That Met QC Criteria: August 2, 2011
• Last Verified: January 1, 2010

More Information

Terms related to this study

• Keywords: percutaneous coronary intervention; contrast-induced nephropathy; creatinine clearance; contrast medium
• Additional Relevant MeSH Terms: Urologic Diseases; Kidney Diseases
• Other Study ID Numbers: 2009X41